NCT00331123

Brief Summary

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
562

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2002

Typical duration for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

May 26, 2006

Last Update Submit

April 15, 2013

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Surgical menopauseHSDD

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy of testosterone transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).

    24 weeks

Secondary Outcomes (1)

  • To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints.

    24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo

Testosterone Patch

EXPERIMENTAL
Drug: Testosterone Transdermal System

Interventions

Testosterone Transdermal SystemDRUG

testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks

Testosterone Patch
PlaceboDRUG

placebo patch,changed every 3-4 days for 24 weeks during double blind phase

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible women must:
  • Be 20-70 years old and in generally good health
  • Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
  • Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
  • Be, in her own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry.
  • Meet the criteria for having hypoactive sexual desire disorder.

You may not qualify if:

  • Eligible women must not:
  • Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
  • Be experiencing any chronic or acute life stress relating to any major life change
  • Be experiencing depression and/or receiving medication for such illness or disorder
  • Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
  • Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
  • Have a history of breast, endometrial, or other gynecological cancer any time before study participation or other cancer within the last 5 years
  • Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
  • Have abnormal laboratory test results upon initial screening for this study
  • Have previously participated in P\&GP study 1999068 or 1999092
  • Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Kansas City, Missouri, United States

Location

Research Site

Prahran, Victoria, Australia

Location

Research Site

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Johna Lucus, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

May 1, 2002

Primary Completion

December 1, 2003

Study Completion

July 1, 2006

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CA(1)AU(1)US(1)