Clinical trial · Interventional
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypoactive Sexual Desire Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo gel | Drug | — | UNRESOLVED |
| testosterone gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- testosterone gel
- description
- 1% testosterone transdermal gel
- interventionNames
- Drug: testosterone gel
- type
- PLACEBO_COMPARATOR
- label
- placebo gel
- description
- placebo transdermal gel
- interventionNames
- Drug: placebo gel
Primary outcomes (1)
- measure
- The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
- timeFrame
- 2011 primary outcome analysis for NDA submission
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Postmenopausal female subjects * at least 50 years of age * with at least two points of cardiovascular risk * with a clinical diagnosis of HSDD. Exclusion Criteria: Subjects must not * require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators, * have used androgen therapy within 2 months of randomization, * have a history of estrogen-dependent neoplasia or any gynecologic cancer, * have a history of cancer of any kind in the past 10 years prior to randomization, * have a history of malignant melanoma or a history of invasive cancer at any time, * have a screening mammogram with any finding that requires follow up within 6 months of randomization, * have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization, * have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.
References
Publications (1)
- DERIVEDWhite WB, Grady D, Giudice LC, Berry SM, Zborowski J, Snabes MC. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. Am Heart J. 2012 Jan;163(1):27-32. doi: 10.1016/j.ahj.2011.09.021. Epub 2011 Nov 21. PMID 22172433