NCT00131495

Brief Summary

This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

August 16, 2005

Last Update Submit

April 15, 2013

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Low LibidoLow DesireDistress

Outcome Measures

Primary Outcomes (1)

  • Total satisfying sexual activity over 24 weeks

    6, 12, 24, 36, and 52 weeks

Secondary Outcomes (5)

  • Sexual desire

    6, 12, 24, 36, and 52 weeks

  • personal distress

    6, 12, 24, 36, and 52 weeks

  • other domains of the Profile of Female Sexual Function over 24 weeks

    6, 12, 24, 36, and 52 weeks

  • mood, energy and well-being

    6, 12, 24, 36, and 52 weeks

  • menopausal symptoms

    6, 12, 24, 36, and 52 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo patch

2

EXPERIMENTAL

Testosterone patch (300mcg/day, changed twice a week for one year

Drug: Testosterone (transdermal patches)

Interventions

Testosterone (transdermal patches)DRUG

Testosterone patch (300mcg/day, changed twice a week for one year

2
Placebo patchDRUG

placebo patch changed twice a week for one year

1

Eligibility Criteria

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

You may qualify if:

  • Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
  • Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
  • Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
  • Answer affirmatively to ALL of the following questions:
  • Was the patient's sex life before menopause good and satisfying in general?
  • Since menopause, has a meaningful loss in the level of desire for sex occurred?
  • Since menopause, has a significant decrease in sexual activity occurred?
  • Is the current level of desire for or interest in sex bothering or concerning?
  • Is an increase in the level of interest in or desire for sex and sexual activity desired?

You may not qualify if:

  • Physical limitations that would interfere with normal sexual function;
  • Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
  • Use of any of the following medications:
  • antiandrogen therapy or topical minoxidil (last 5 years),
  • androgen therapy (past 3 months/implantable past 7 months),
  • systemic corticosteroids,
  • selective serotonin reuptake inhibitors (SSRIs),
  • tricyclic anti-depressants,
  • anti-androgens,
  • systemic beta-blockers,
  • anti-adrenergics,
  • spironolactone,
  • apomorphine,
  • phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks))
  • Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash Medical School, The Alfred Hospital

Prahran, Victoria, VIC 3181, Australia

Location

Related Publications (1)

  • Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.

    PMID: 18987368DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sue Davis, MD

    Monash Medical School, The Alfred Hospital

    PRINCIPAL INVESTIGATOR

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

August 16, 2005

First Posted

August 18, 2005

Study Start

July 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2007

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

AU(1)