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Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Testosterone
Placebo
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

300mcg/day testosterone

Placebo arm

Outcomes

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.

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.

Full Information

First Posted
October 3, 2006
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00384046
Brief Title
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
300mcg/day testosterone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patch, placebo, patch changed every 3-4 days, 24 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran A Lodhi, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Ashfield
State/Province
New South Wales
ZIP/Postal Code
2131
Country
Australia
Facility Name
Research Facility
City
Gordon
State/Province
New South Wales
ZIP/Postal Code
2072
Country
Australia
Facility Name
Research Facility
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Research Facility
City
Dulwich
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Research Facility
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Research Facility
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Facility
City
Freiburg
State/Province
DEU
ZIP/Postal Code
D-79085
Country
Botswana
Facility Name
Research Facility
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1P6
Country
Canada
Facility Name
Research Facility
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Research Facility
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Research Facility
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Research Facility
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Site Facility
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Research Facility
City
Solihull
State/Province
West Midlands
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Research Facility
City
Atherstone
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Research Facility
City
Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Research Facility
City
Doncaster
ZIP/Postal Code
DN1 2ET
Country
United Kingdom
Facility Name
Research Facility
City
Headington
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Research Facility
City
Herts
ZIP/Postal Code
SG6 4TS
Country
United Kingdom
Facility Name
Research Facility
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Research Facility
City
Leicester
ZIP/Postal Code
LW1 5WW
Country
United Kingdom
Facility Name
Research Facility
City
Lichfield
ZIP/Postal Code
WS14 9LH
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
NW8 9NH
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
SW1W 8RH
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
W1G 7JW
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Research Facility
City
Plymouth
ZIP/Postal Code
PL4 8QU
Country
United Kingdom
Facility Name
Research Facility
City
Salford
ZIP/Postal Code
M8 8HD
Country
United Kingdom
Facility Name
Research Facility
City
Warks
ZIP/Postal Code
CV9 1EU
Country
United Kingdom

12. IPD Sharing Statement

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Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

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