Phase 3
N=1,271
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Hypoactive Sexual Desire Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00467259 ↗Enrolled (actual)
1,271
Serious AEs
3.4%
Results posted
Dec 2011
Primary outcome: Primary: Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 — 0; 0 # Endometrial Hyperplasia/Evaluable Biop — p=1.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone Transdermal System (Drug); Placebo patch (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 |
0; 0 | 1.0000 |
| SECONDARY Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 |
0; 0 | 1.0000 |
| SECONDARY Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 |
0; 0 | 1.0000 |
Summary
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
Eligibility Criteria
Inclusion Criteria
- Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Exclusion Criteria
- Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
Data sourced from ClinicalTrials.gov (NCT00467259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.