NCT01382719

Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

A Placebo-controlled, Randomized, Parallel Group, Dose-finding Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With FSAD (Female Sexual Arousal Disorder) and/or HSDD (Hypoactive Sexual Desire Disorder)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.

Conditions

• Female Sexual Arousal Disorder
• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	bremelanotide	Subjects will administer drug on an as needed basis, prior to anticipated sexual activity. Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-06-27
• Last updated: 2014-12-18
• Results posted: 2014-04-14

Locations

68 sites across 2 countries: United States, Canada