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NCT00612742 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

A Phase 3 study, sponsored by BioSante Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
3,656
Enrollment target

NCT00612742: Completed Phase 3 study, sponsored by BioSante Pharmaceuticals.

NCT00612742 is a Phase 3 study that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 3,656 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (374% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00612742, a Phase 3 study, has completed, sponsored by BioSante Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
3,656 participants
Enrollment target

Study Summary

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).

Interventions

  • DRUG testosterone gel
  • DRUG placebo gel

Trial Details

FieldValue
Enrollment Target 3,656 participants
Start Date 2008-01
Est. Completion 2012-12
Phase Phase 3
BioSante Pharmaceuticals

4 total trials

What the finished NCT00612742 record still lists

NCT00612742 is an interventional study that assigns participants to a tested intervention. Its 3,656 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (374% higher).

The record links to 0 conditions, and to 2 interventions - of which testosterone gel is the first listed.

NCT00612742 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00612742 about?

NCT00612742 is a clinical study titled "Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women". 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 ...

What is the current status of trial NCT00612742?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,656 participants. The study started on 2008-01. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00612742?

The interventions under investigation include: testosterone gel (DRUG), placebo gel (DRUG).

Who is sponsoring clinical trial NCT00612742?

This trial is sponsored by BioSante Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00612742's enrollment target sits among peer trials

3,656 67th of 2000 higher than 1,934 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00612742, the US trial registry maintained by the National Library of Medicine. NCT00612742 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.