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NCT01432665 · ClinicalTrials.gov registry record · Phase 2
Lybrido for Female Sexual Dysfunction
A Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
- 14
- Study locations
NCT01432665: Completed Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
NCT01432665 is a Phase 2 study of Hypoactive Sexual Desire Disorder that has completed, run by Emotional Brain NY. The registered enrollment target is 196 participants, below the 380-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (48% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01432665, a Phase 2 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by Emotional Brain NY.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
- 14
- Study locations
Study Summary
The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).
Primary Outcome
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Testosterone
- DRUG Sildenafil
Study Locations (14)
Florida
- Meridien Research - Brooksville
- Segal Institute Women's Health Clinic - North Miami
- Compass Research - Orlando
- Miami Research Associates - South Miami
- Meridien Research - St. Petersburg
- Comprehensive Clinical Trials, LLC - West Palm Beach
Maryland
- Annapolis Sexual Wellness Center - Annapolis
- Maryland Prime Care Physicians - Stevensville
- Center for Sexual Medicine at Sheppard Pratt - Townson
California
- San Diego Sexual Medicine - San Diego
District of Columbia
- The Center for Vulvovaginal Disorders - Washington D.C.
New Jersey
- Women's Health Research Center - Plainsboro
New York
- Michael A. Werner, MD PC - Purchase
Pennsylvania
- Philadelphia Clinical Research - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2011-09 |
| Phase | Phase 2 |
What the finished NCT01432665 record still lists
NCT01432665 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 380-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01432665 lists 14 locations in 7 states (Florida, Maryland, California).
Frequently Asked Questions
What is clinical trial NCT01432665 about?
NCT01432665 is a clinical study titled "Lybrido for Female Sexual Dysfunction". The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of ...
What is the current status of trial NCT01432665?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2011-09.
What conditions does trial NCT01432665 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT01432665?
The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01432665?
This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01432665 being conducted?
This trial has 14 study locations across California, District of Columbia, Florida, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01432665's enrollment target sits among peer trials
196 6th of 8 higher than 3 of 8 other Hypoactive Sexual Desire Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoactive Sexual Desire Disorder 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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