Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02714049

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:
Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Clinical Trial Summary

Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.

Clinical Trial Description

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks. ;

Study Design

Related Conditions & MeSH terms

  • Hypoactive Sexual Desire Disorder
  • Hypokinesia
  • Sexual Dysfunctions, Psychological
Clinical Trial Details
NCT number NCT02714049
Study type Interventional
Source San Diego Sexual Medicine
Contact
Status Terminated
Phase Phase 4
Start date January 25, 2017
Completion date January 30, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01432665 - Lybrido for Female Sexual Dysfunction Phase 2
Terminated NCT00551785 - Surveillance Study of Women Taking Intrinsa® Phase 4
Completed NCT03232801 - A Mindfulness-based Intervention for Older Women With Low Sexual Desire N/A
Recruiting NCT04179734 - Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder Phase 4
Terminated NCT02770768 - Effects of Flibanserin on the Pre- and Post-menopausal Female Brain N/A
Completed NCT01235754 - Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT03287232 - Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT00384046 - Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen Phase 3
Completed NCT00331123 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
Recruiting NCT04943068 - A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) Phase 3
Completed NCT03463707 - BP101 for Adults With Female Sexual Dysfunction Phase 3
Completed NCT01208038 - Testosterone Patch's Effects on the Cardiovascular System and Libido Phase 4
Completed NCT00657501 - Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women Phase 3
Completed NCT04336891 - Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Completed NCT01382719 - Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder Phase 2
Recruiting NCT00916396 - Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder N/A
Completed NCT00034021 - Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction Phase 2
Completed NCT00338312 - Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido Phase 3
Completed NCT00331214 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3