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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00131495




Registration number
NCT00131495
Ethics application status
Date submitted
16/08/2005
Date registered
18/08/2005
Date last updated
17/04/2013

Titles & IDs
Public title
Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
Scientific title
A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
Secondary ID [1] 0 0
2004031 and Yr 2 SB
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoactive Sexual Desire Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone (transdermal patches)
Treatment: Drugs - Placebo patch

Placebo comparator: 1 - Placebo patch

Experimental: 2 - Testosterone patch (300mcg/day, changed twice a week for one year


Treatment: Drugs: Testosterone (transdermal patches)
Testosterone patch (300mcg/day, changed twice a week for one year

Treatment: Drugs: Placebo patch
placebo patch changed twice a week for one year
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total satisfying sexual activity over 24 weeks
Timepoint [1] 0 0
6, 12, 24, 36, and 52 weeks
Secondary outcome [1] 0 0
Sexual desire
Timepoint [1] 0 0
6, 12, 24, 36, and 52 weeks
Secondary outcome [2] 0 0
personal distress
Timepoint [2] 0 0
6, 12, 24, 36, and 52 weeks
Secondary outcome [3] 0 0
other domains of the Profile of Female Sexual Function over 24 weeks
Timepoint [3] 0 0
6, 12, 24, 36, and 52 weeks
Secondary outcome [4] 0 0
mood, energy and well-being
Timepoint [4] 0 0
6, 12, 24, 36, and 52 weeks
Secondary outcome [5] 0 0
menopausal symptoms
Timepoint [5] 0 0
6, 12, 24, 36, and 52 weeks

Eligibility
Key inclusion criteria
* 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:

1. Was the patient's sex life before menopause good and satisfying in general?
2. Since menopause, has a meaningful loss in the level of desire for sex occurred?
3. Since menopause, has a significant decrease in sexual activity occurred?
4. Is the current level of desire for or interest in sex bothering or concerning?
5. Is an increase in the level of interest in or desire for sex and sexual activity desired?
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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;
* Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
* Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch
* Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
* Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study.
* Have significant abnormal pretreatment laboratory parameters.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
814
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical School, The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
VIC 3181 - Prahran

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Warner Chilcott
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00131495
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Sue Davis, MD
Address 0 0
Monash Medical School, The Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00131495