Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder (NCT01607658), a randomized phase 2 study. The primary outcome is Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period.

2. Clinical Question

This question concerns a count of orgasms over a specified treatment period, summarized as an average across the participants represented in each group. A group mean gives a concise comparison, but does not show how individual counts were distributed. The standard deviations indicate that individual observations varied around the group means; they do not describe the full shape of those distributions.

The three dose groups allow the posted results to be considered separately by dose rather than treated as a single active-treatment group. The central statistical issue is whether the observed differences are estimated precisely enough to distinguish them from no difference, not simply which group mean is numerically highest. The confidence intervals are important for that interpretation, particularly because each includes zero.

3. Trial Design

The registry describes a completed phase 2 study with randomized allocation, double masking, and a parallel-group model. Its official title identifies the study as placebo-controlled and dose-finding. The condition listed is female orgasmic disorder, and the study title specifies acquired female orgasmic disorder. Enrollment was 253. The registry record lists the start as 2012-05 and primary completion as 2014-05.

Participants were assigned to placebo or one of three TBS-2 intranasal testosterone gel dose groups. The experimental doses were 0.6 mg, 1.2 mg, and 1.8 mg. The placebo description specifies administration as needed, 2-8 hours before a planned sexual event; the experimental arm descriptions specify administration as needed. The registry record does not report further detail about administration beyond those descriptions.

Randomization is intended to create groups that are comparable on average at the start of a study, while masking is intended to limit the influence of treatment knowledge on participants and study personnel. Those are general design purposes, not evidence that every possible source of bias was eliminated in this trial. A parallel-group design means the posted arm comparisons are between groups rather than within the same participants under different assignments.

The primary endpoint is reported for the ITT Population. The registry record does not report the full operational definition of that population, details of randomization or masking procedures, or the protocol’s original sample-size justification. The registry record lists four outcome measures and three secondary outcomes. Although the trial is marked completed, the registry record does not report a detailed account of study conduct or participant flow.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: ITT Population

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: ITT population

6. Primary Endpoint

The registry lists the primary outcome as Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period, measured over 84 days.

The primary endpoint is the number of orgasms over an 84-day period, compared with placebo over the entire treatment period. The registry record gives the unit as orgasms, identifies the summary as a mean, and reports a standard deviation for each group. The outcome is described for the ITT Population.

A mean is useful for comparing the average observed outcome between randomized groups. In this setting, it condenses each group’s orgasm counts over the treatment period into a common summary, and the mean difference expresses how far a dose-group mean is from the placebo mean. A positive difference means the dose-group mean is numerically higher than the placebo mean; a negative difference means it is numerically lower. These directions describe the reported outcome and do not, by themselves, establish a causal or clinical conclusion.

The endpoint is relevant to the study’s stated purpose of comparing the effects of three dose strengths with placebo on the occurrence of orgasm. A standard deviation accompanies each mean to show the spread of observations around that average. Because counts can vary between participants, reporting only means would give an incomplete account of the observed data. The registry record does not report details of the instrument or diary used to capture orgasms, the handling of incomplete observation periods, or any additional endpoint definition beyond the stated measure and timeframe.

7. Results Posted in the Registry

• Low Dose TBS-2: mean 3.90 versus 2.80 on control; difference 1.10 (95% CI -0.58 to 2.78), standardized effect d = 0.22; z-test p = 0.199.
• Medium Dose TBS-2: mean 3.20 versus 2.80 on control; difference 0.40 (95% CI -1.25 to 2.05), standardized effect d = 0.09; z-test p = 0.634.
• High Dose TBS-2: mean 1.90 versus 2.80 on control; difference -0.90 (95% CI -2.31 to 0.51), standardized effect d = -0.22; z-test p = 0.211.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Low Dose TBS-2: mean 1.52 versus 1.37 on control; difference 0.15 (95% CI -0.45 to 0.75), standardized effect d = 0.09; z-test p = 0.626.
  • Medium Dose TBS-2: mean 1.59 versus 1.37 on control; difference 0.22 (95% CI -0.45 to 0.89), standardized effect d = 0.13; z-test p = 0.522.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Low Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Medium Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.

Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Low Dose TBS-2: mean -1.30 versus -0.90 on control; difference -0.40 (95% CI -0.86 to 0.06), standardized effect d = -0.32; z-test p = 0.092.
  • Medium Dose TBS-2: mean -0.90 versus -0.90 on control; difference 0.00 (95% CI -0.42 to 0.42), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Low Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Medium Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.

Change in Global Sexual Functioning From Day 0 to Day 84

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Low Dose TBS-2: mean 3.42 versus 2.90 on control; difference 0.52 (95% CI -1.73 to 2.77), standardized effect d = 0.09; z-test p = 0.650.
  • Medium Dose TBS-2: mean 3.33 versus 2.90 on control; difference 0.43 (95% CI -2.01 to 2.87), standardized effect d = 0.07; z-test p = 0.730.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Low Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Medium Dose TBS-2 and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover sexual event satisfaction, distress due to female orgasmic disorder, and global sexual functioning. Their posted summaries use changes over the stated baseline and end-of-study periods. Across these outcomes, the means do not form a uniform pattern in which every measure moves in the same direction across dose groups. Nor do the observed means establish a consistent dose-response pattern that reinforces the primary outcome.

These outcomes can add context because they describe related aspects of participants’ experiences rather than the primary count alone. They do not replace the primary endpoint, and differences in outcome scale, timeframe, and available group sample size mean that the results should not be treated as interchangeable. The registry record does not report formal secondary analyses, and the posted recalculated comparisons are limited to the comparisons included with the outcome summaries.

Unadjusted secondary results carry less inferential weight when several outcomes and comparisons are considered. In general, examining more hypotheses increases the chance that some results will appear noteworthy through random variation alone. A multiplicity procedure can address that issue, but the registry record does not report whether one was planned or applied. The secondary estimates and confidence intervals are therefore best treated as exploratory descriptions rather than independent confirmation of the primary result.

There is also no basis in the registry record for deciding whether the secondary outcomes were prespecified in the same way as the primary endpoint, how they were prioritized, or whether missing observations affected their analyses. The secondary summaries may inform questions for future research, but they do not resolve the uncertainty around the primary comparisons or provide a reported, adjusted body of evidence across outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
• Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84
• Change in Global Sexual Functioning From Day 0 to Day 84

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous in the registry’s statistical summary because the posted comparison uses group means, even though the underlying measure is a count. The registry record describes the parameter as a mean and the dispersion measure as a standard deviation. A mean difference is obtained by comparing the group averages; the posted estimates are 1.1 for low dose, 0.4 for medium dose, and -0.9 for high dose relative to the placebo mean of 2.8.

What does a mean difference represent?

In general, a mean difference expresses the average outcome in one group relative to the average in another group, using the same outcome scale. Zero represents no difference between the group means. A positive estimate indicates a higher mean in the dose group than in placebo, while a negative estimate indicates a lower mean. The size and direction of an estimate should be considered with its confidence interval, because a point estimate alone does not show how uncertain the comparison is.

For these comparisons, the confidence intervals include zero. That means the ranges of values compatible with the posted estimates include no mean difference. It does not mean that the true difference has been shown to be zero. In general, a confidence interval reflects the uncertainty of an estimate under the assumptions of the method used; it is not a range that guarantees the true value lies within it, nor a probability statement about a particular treatment effect.

Why report a standard deviation?

The standard deviation describes the spread of observations around a group mean. The reported standard deviations are large relative to the group means, so the averages do not imply that most individual participants had counts close to the mean. This comparison of scale is descriptive; it does not recover the outcome distribution. The registry record does not report individual-level data, medians, quantiles, or the proportion of participants with no recorded orgasms.

In general, count outcomes can be skewed or contain more variability than a simple statistical model expects. Over-dispersion means that the observed variability is greater than the model’s assumed variability. If over-dispersion is present and not handled appropriately, standard errors and confidence intervals from a model that assumes less variability may be too small. The posted primary comparisons are recalculations based on group summaries, and the registry record does not report a model-based analysis of the count distribution or a test for over-dispersion. It is therefore not possible to determine from the record whether such features were assessed in the trial’s own analysis.

What do the p-values add?

The posted unadjusted p-values are 0.199 for low dose, 0.634 for medium dose, and 0.211 for high dose. In general, a p-value evaluates how unusual data at least as incompatible with a specified null hypothesis would be under that hypothesis and the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the magnitude or practical importance of a difference. Because these values are unadjusted, they do not incorporate a correction for considering multiple dose comparisons or outcomes.

The registry record reports no sponsor analyses for these endpoints. The displayed comparison statistics are unadjusted recalculations using the posted means, standard deviations, and group sample sizes. They can help readers understand the scale and uncertainty of the summaries, but they are not a substitute for a prespecified analysis using participant-level data. The record does not report the trial’s statistical plan, model specification, covariate adjustment, or multiplicity procedure. Those omissions limit what can be concluded about how the trial’s original inferential analyses were conducted.

Why can variability matter for a count endpoint?

General statistical methods for count outcomes may use distributional assumptions tailored to counts, while a comparison of means emphasizes the average. The choice of method affects estimates of uncertainty, especially when outcomes are unevenly distributed or more variable than expected. The posted summaries alone cannot determine the best-fitting model. They also cannot reveal whether the groups differed in the distribution of counts even when the means are similar. Individual-level analyses would be needed to assess those questions, and such analyses are not reported in the registry record.

Finally, randomized assignment supports a comparison between groups in principle, but the interpretation also depends on how outcomes were collected and how missing observations were handled. The registry record identifies the primary population as ITT but does not explain which participants or observations were included in each endpoint calculation, how missing data were treated, or whether additional sensitivity analyses were performed. These are general considerations for interpreting trial results, not claims that a particular problem occurred in this study.

11. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimate. The primary comparisons report confidence intervals for the difference in mean orgasm counts between each TBS-2 dose and placebo. Every posted primary confidence interval includes zero. Thus, the data summaries are compatible with no mean difference as well as with differences in either direction; the intervals do not isolate a single precise effect.

The low-dose estimate is positive, the medium-dose estimate is also positive but closer to zero, and the high-dose estimate is negative. The corresponding intervals extend across zero, so the direction of each observed estimate should not be mistaken for a settled direction of the underlying difference. The interval widths also show that the estimates allow a range of possible effects, rather than tightly specifying the size of a dose-versus-placebo difference.

In general, a confidence interval combines an estimate with its sampling uncertainty under the statistical method’s assumptions. Greater precision is usually reflected by a narrower interval. Interval width is influenced by variability and the amount of information contributing to an estimate. The standard deviations reported for the primary endpoint are substantial relative to the means, which helps explain why the means alone do not convey the uncertainty of the comparisons.

Confidence intervals do not address every source of uncertainty. They do not account automatically for bias, the choice of outcome definition, missing-data assumptions, or multiplicity. The registry record does not report sponsor analyses, an adjustment for multiple comparisons, or details of missing-data handling. The intervals should therefore be read as precision estimates for the posted, unadjusted comparisons, not as a complete measure of uncertainty about all aspects of the trial.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are expressed as participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is set to the stated fraction of the observed effect for the comparison. These are planning illustrations based on the observed estimates, not the trial’s original design assumptions, which are not reported in the registry record.

For the primary comparisons, the planning illustration for 100% of the observed effect gives 315 participants per arm for 80% power and 422 participants per arm for 90% power for low dose. For medium dose, the corresponding figures are 2,120 and 2,837 participants per arm. For high dose, they are 324 and 433 participants per arm. The large variation reflects the different observed effect estimates in relation to the variability in each comparison; it is not evidence that the original trial planned those group sizes.

The rows for 75% and 50% of the observed effect show how planning changes when the effect to detect is smaller. For low dose, the figures for 75% are 560 participants per arm for 80% power and 749 for 90% power; for 50%, they are 1,259 and 1,685. For medium dose, the figures are 3,768 and 5,044 for 75%, and 8,477 and 11,348 for 50%. For high dose, they are 575 and 770 for 75%, and 1,293 and 1,731 for 50%.

In general, 80% power means an 80% chance of detecting the specified effect under the planning assumptions if that effect is present; 90% power describes a higher chance under those same assumptions. Smaller effects require more participants to detect because they are harder to distinguish from random variation. These figures are planning illustrations, not observed power. They do not show the probability that the trial’s findings are true or the probability that a particular treatment effect exists.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.100; pooled standard deviation σ = 4.925.
2. n = 2 × (1.96 + 0.842)² × 4.925² / 1.100² = 314.6, rounded up to 315 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.1                      # observed difference in means
sigma <- 4.92453387095204                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1607658)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 315 (80% power), 422 (90% power)
 75% of observed effect: n per arm = 560 (80% power), 749 (90% power)
 50% of observed effect: n per arm = 1,259 (80% power), 1,685 (90% power)
power.t.test: 315.6 
Simulated power at n = 315 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The primary outcome has three dose-versus-placebo comparisons, and the registry record also lists three secondary outcomes. When researchers assess several comparisons, the chance of at least one apparently notable result can increase. In general, multiplicity methods are used to control or describe that risk, depending on the analysis plan. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a prespecified testing strategy. The posted p-values are unadjusted, so they should not be interpreted as if they account for the full set of outcomes and comparisons.

The record lists the primary population as ITT Population. That label indicates the intended analysis population named for the primary endpoint, but the registry record does not define its membership or describe how participants with incomplete outcome data were handled. The record also does not report whether the secondary outcomes used the same analysis population. Group-specific sample sizes vary across the posted outcomes, but the record does not explain the reasons for those differences. They cannot, on their own, establish why observations were unavailable or whether missingness could have influenced results.

For general context, missing-data methods rely on assumptions about why observations are absent. Different assumptions can lead to different estimates, particularly when missingness is related to outcomes or treatment assignment. The registry record does not report imputation methods, sensitivity analyses, or an assessment of missing-data mechanisms. It is therefore not possible to evaluate the robustness of the posted summaries to missing observations from the registry record alone.

The registry record does not report the original statistical analysis plan, interim analyses, or sample-size justification. It also contains no reported analyses for the listed outcomes. The confidence intervals and p-values available with the posted summaries are unadjusted recalculations, not evidence of a fully reported sponsor analysis. These gaps limit assessment of prespecification, selective reporting, and the relationship between the planning assumptions and the trial’s conduct.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 3% reporting threshold.

Most frequent non-serious adverse event terms

The posted serious adverse event figures report zero affected participants in each group: placebo, low dose, medium dose, and high dose. The registry record also reports zero deaths in each group. The risk groups listed for these summaries are 65 for placebo, 67 for low dose, 58 for medium dose, and 63 for high dose.

These figures describe what was recorded in the registry for the groups and safety categories shown. A zero count in a trial summary does not establish that an event is impossible or that there is no safety risk. It means no affected participants were reported for that category in these posted results. The group sizes and duration of observation matter when interpreting an absence of reported events, and the summaries do not provide a basis for detecting rare risks.

The record separately reports other adverse events affecting participants, but those counts are not serious adverse event counts. Serious-event figures should not be combined with other adverse-event figures or interpreted as a complete account of tolerability. The registry record does not report serious adverse event terms, and it does not provide detailed information about event definitions, timing, severity, or causality assessment.

16. What the Result Does, and Does Not, Mean

The posted primary summaries show that the group means over 84 days differed from the placebo mean in different directions: the low- and medium-dose means were higher, while the high-dose mean was lower. Each dose-versus-placebo confidence interval includes zero. The results therefore do not estimate a precise, clearly nonzero difference for any of the three primary comparisons. They describe the observed averages and uncertainty in the recalculated comparisons; they do not establish that the groups are identical.

The findings also do not demonstrate a consistent increase in the mean count with increasing dose. A pattern across group means should not be interpreted as proof of a dose effect or absence of one, especially when the estimates are imprecise and the registry record does not report a sponsor analysis or dose-trend test. Likewise, an unadjusted p-value does not determine whether an observed difference is important to participants.

Clinical importance is not established by statistical significance alone. The registry record does not report a threshold for a meaningful change in orgasm counts, nor does it explain how the endpoint relates to a participant’s overall experience. The secondary outcomes concern satisfaction, distress, and global sexual functioning, but the record does not report formal analyses or a multiplicity strategy that would support treating them as confirmatory evidence.

These results are specific to the enrolled trial population, the treatment period, the recorded outcome, and the analysis summaries available in the registry. They do not establish what would happen in other populations, under other conditions of use, or over a different timeframe. No medical advice or treatment recommendation follows from these statistical summaries. A fuller interpretation would require the trial’s analysis plan, outcome collection details, missing-data methods, and complete reported analyses, which are not reported in the registry record.

17. Why This Trial Matters Statistically

This trial illustrates why the numerical direction of an observed mean is only a starting point for interpretation. The three dose groups have different mean differences from placebo, but all primary confidence intervals include zero. Reading estimates together with their intervals makes clear that the direction of a point estimate does not settle the direction or size of the underlying effect.

It also illustrates the information limits of group summaries. The outcome is reported as a mean and standard deviation, but those statistics cannot show the distribution of individual counts. When the spread is large relative to the average, a mean alone may not describe what is typical for a participant. The registry record does not report individual-level distributions or analyses tailored to the count outcome, so readers cannot assess those features directly.

The dose-finding context makes consistency across dose groups an important statistical question. The posted means do not follow a steadily increasing pattern across the doses. That observation is informative as a description, but it is not a formal test of a dose-response relationship. The record does not report such a test or the analysis plan needed to evaluate whether it was intended.

Finally, the planning illustrations show how strongly sample-size requirements depend on the effect used for planning and the variability in the outcome. Their figures are derived from observed estimates and stated assumptions, whereas the original design justification is not reported in the registry record. Keeping those planning illustrations separate from the trial’s design history prevents a common misreading: an illustrative calculation is not evidence that a trial was designed with that target or that its achieved sample size had a particular power.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves important trial-specific details unreported. It does not give the original statistical analysis plan, the sample-size justification, the operational definition of the ITT Population, or the methods used to handle incomplete observations. It also does not report a sponsor analysis for the posted outcomes. As a result, the recalculated comparisons cannot be checked against a prespecified model or a complete analysis of participant-level data.

The primary endpoint is summarized as a mean and standard deviation for a count outcome. The record does not provide the underlying distribution, individual participant data, or an analysis addressing whether the count data were unevenly distributed or over-dispersed. The group summaries cannot show how many participants had a particular count or whether a small number of observations influenced the means.

The confidence intervals and p-values for the posted comparisons are unadjusted. The record does not report a multiplicity strategy despite the presence of several dose comparisons and secondary outcomes. The secondary outcome summaries also have varying group sample sizes, and the registry record does not explain the differences or describe their missing-data handling.

The reported outcome covers 84 days. This limits what the endpoint can say about outcomes beyond that treatment period. The registry record does not provide a threshold for clinical importance, detailed outcome-collection procedures, or serious adverse event terms. These are limitations of the information available in the registry record; they do not establish that any particular design or conduct problem occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder — NCT01607658.
• Registry record last updated 2018-08-13; status last verified 2018-08.
• Results first posted 2018-08-13.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

The registry record describes a completed, randomized, double-blind, parallel-group phase 2 trial of placebo and three doses of TBS-2 intranasal testosterone gel in women with acquired female orgasmic disorder. Enrollment was 253. The primary endpoint was the mean number of orgasms over an 84-day period in the ITT Population.

The posted primary means were 2.8 for placebo, 3.9 for low dose, 3.2 for medium dose, and 1.9 for high dose. Each recalculated, unadjusted dose-versus-placebo confidence interval includes zero. The registry record lists three secondary outcomes but no reported analyses for those outcomes, and it does not report the original statistical analysis plan or sample-size justification. Serious adverse event and death counts were zero in each group in the posted safety summaries.