Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00384046

Purpose

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.

Condition	Intervention	Phase
Hypoactive Sexual Desire Disorder	Drug: Testosterone Drug: Placebo	Phase III

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters. [ Time Frame: Assessment at 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires. [ Time Frame: Assessment at 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 300mcg/day testosterone	Drug: Testosterone patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
2: Placebo Comparator Placebo arm	Drug: Placebo patch, placebo, patch changed every 3-4 days, 24 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.

Exclusion Criteria:

Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384046

Show 31 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Imran A Lodhi, MD

Procter and Gamble

More Information

Responsible Party:	Procter and Gamble Pharmaceuticals ( Imron Lodhi, MD )
Study ID Numbers:	2005108
Study First Received:	October 3, 2006
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00384046
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Signs and Symptoms
Testosterone
Mental Disorders
Neurologic Manifestations

Methyltestosterone
Hypokinesia
Dyskinesias
Menopause
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sexual and Gender Disorders

Hormones
Pharmacologic Actions
Anabolic Agents
Pathologic Processes
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on January 16, 2009