Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
Phase of Trial: Phase III
Latest Information Update: 26 Mar 2018
At a glance
- Drugs Bremelanotide (Primary)
- Indications Female sexual dysfunction
- Focus Registrational; Therapeutic Use
- Acronyms RECONNECT
- Sponsors Palatin Technologies
- 26 Mar 2018 According to an AMAG Pharmaceuticals media release, based on the data from two Phase 3 trials (this and CTP 253197), the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women in February 2017.
- 27 Feb 2017 Results published in an AMAG Pharmaceuticals media release.
- 27 Feb 2017 According to an AMAG Pharmaceuticals media release, additional results from the study were presented at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History