Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
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 |
NCT00338312 -
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
|
Phase 3 | |
Completed |
NCT00034021 -
Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
|
Phase 2 | |
Completed |
NCT00331214 -
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
|
Phase 3 | |
Recruiting |
NCT02968342 -
Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
|
Phase 4 |