Trial · NCT00467259
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
NCT00467259, Phase 3, Completed, Warner Chilcott; results first posted 2011-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women. Trials, record NCT00467259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
- NCT number
- NCT00467259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,271 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Testosterone Transdermal System, Placebo patch
- First posted
- 2007-04-30
- Last updated
- 2011-12-15
- Results first posted
- 2011-12-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 | 52 weeks | Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies |
| Secondary | Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 | 52 weeks | Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies |
| Secondary | Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 | 52 weeks | Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 | 52 weeks | Subjects with evaluable endometrial biopsies. | # Endometrial Hyperplasia/Evaluable Biop | NUMBER |
| SECONDARY | Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 | 52 weeks | Subjects with evaluable endometrial biopsies. | # Endometrial Hyperplasia/Evaluable Biop | NUMBER |
| SECONDARY | Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 | 52 weeks | Subjects with evaluable endometrial biopsies. | # Endometrial Hyperplasia/Evaluable Biop | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 | Placebo | 0 | 95% Confidence Interval 0 to 2.6 | # Endometrial Hyperplasia/Evaluable Biop | |
| Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 | Testosterone | 0 | 95% Confidence Interval 0 to 0.6 | # Endometrial Hyperplasia/Evaluable Biop | |
| Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 | Placebo | 0 | 95% Confidence Interval 0 to 26.7 | # Endometrial Hyperplasia/Evaluable Biop | |
| Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 | Testosterone | 0 | 95% Confidence Interval 0 to 5.2 | # Endometrial Hyperplasia/Evaluable Biop | |
| Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 | Placebo | 0 | 95% Confidence Interval 0 to 2.4 | # Endometrial Hyperplasia/Evaluable Biop | |
| Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 | Testosterone | 0 | 95% Confidence Interval 0 to 0.5 | # Endometrial Hyperplasia/Evaluable Biop |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 251 | |
| Overall Study | STARTED | Testosterone | 1,020 | |
| Overall Study | ITT Population | Placebo | 251 | |
| Overall Study | ITT Population | Testosterone | 1,019 | |
| Overall Study | COMPLETED | Placebo | 176 | |
| Overall Study | COMPLETED | Testosterone | 778 | |
| Overall Study | NOT COMPLETED | Placebo | 75 | |
| Overall Study | NOT COMPLETED | Testosterone | 242 |
Source ClinicalTrials.gov
Adverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 251 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Testosterone | 8 | 1,019 | 9 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 251 | 5 |
| other | Nausea | Gastrointestinal disorders | Testosterone | 10 | 1,019 | 11 |
| other | Application Site Reaction | General disorders | Placebo | 47 | 251 | 50 |
| other | Application Site Reaction | General disorders | Testosterone | 180 | 1,019 | 196 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 11 | 251 | 12 |
| other | Nasopharyngitis | Infections and infestations | Testosterone | 22 | 1,019 | 26 |
| other | Sinusitis | Infections and infestations | Placebo | 5 | 251 | 5 |
| other | Sinusitis | Infections and infestations | Testosterone | 25 | 1,019 | 27 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Testosterone | ||
| Total, other adverse events | Placebo | 125 | 251 |
| Total, other adverse events | Testosterone | 472 | 1,019 |
| Total, serious adverse events | Placebo | 10 | 251 |
| Total, serious adverse events | Testosterone | 33 | 1,019 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Testosterone vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00467259
GET https://conductscience.org/api/trials/v1/NCT00467259/events?page=2