A Randomised, Double-Blind, Placebo-Controlled, Parallel-group, Multicentre, 24 week Study to Evaluate the Efficacy and Safety of Transdermal Testosterone (300 mcg/day) in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen, Oral Non-Conjugated Equine Estrogen, or No Estrogen Therapy - ADORE

Procter & Gamble Pharmaceuticals0 sites270 target enrollmentJune 19, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Procter & Gamble Pharmaceuticals
Enrollment: 270
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 19, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Procter & Gamble Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Women will be screened for study participation according to the following inclusion criteria at Week –4\. Eligible women must:
•a) be 40 to 70 years old and in general good health based on medical history, physical examination, and laboratory evaluation;
•b) have no spontaneous menstrual periods for 1 year (if post\-hysterectomy, the woman must have at least 1 ovary. For hysterectomised women \< 50 years of age, a screening follicle stimulating hormone \[FSH] level \> 30 IU/L is required to confirm
•menopausal status (a previously documented FSH level in the clinical notes of
•\> 30 IU/L confirming the menopausal transition will also be acceptable);
•c) be receiving a stable dose of an approved systemic transdermal estrogen or oral non\-CEE (estrogen implants are not acceptable), if hysterectomised, or an approved
•continuous systemic transdermal estrogen or oral non\-CEE plus transdermal or oral
•progestogen, if not hysterectomised, for at least 12 weeks prior to screening with the intention of maintaining that regimen throughout the study or not currently receiving any hormone replacement therapy (having stopped hormone replacement therapy at least 12 weeks before screening) with the intention of not starting hormone replacement therapy during the study;
•d) have a clinically acceptable screening bilateral mammogram (no evidence of malignancy) as determined by a local radiologist. A clinically acceptable mammogram is one in which the report requests a follow\-up in the standard timeframe. A documented result of a previous mammogram done up to 1 year prior to screening is acceptable; for clinical sites in Germany, a screening bilateral mammogram by a local radiologist will not be performed; only documented results from a previous mammogram done up to 1 year prior to screening will be used to assess eligibility;
•e) have a clinically acceptable Pap smear (no evidence of malignancy or squamous intraepithelial lesions) if the cervix is present. A Pap smear at study entry may be performed on patients without a cervix at the discretion of the investigator;

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:
•a) have dyspareunia not alleviated by lubricants, any physical limitations, or sexual trauma that would interfere with normal sexual function;
•b) have received marketed or investigational oral, sub\-lingual, topical, transdermal injectable, or vaginal androgen therapy at any time during the past 3 months, or investigational implantable androgen therapy at any time during the past 7 months;
•c) have received anti\-androgen therapy or topical minoxidil for androgenic alopecia within the last 5 years;
•d) have used within the last 12 weeks any of the following medications/preparations that may affect sexual function or otherwise interfere with interpretation of the study results: systemic corticosteroids (acute use for less than 7 days is accepted), non\-selective and selective serotonin reuptake inhibitors, tricyclic anti\-depressants, systemic beta\-blockers , anti\-adrenergics, spironolactone, apomorphine, PDE5 inhibitors (e.g., Viagra), tibolone, or selective estrogen receptor modulators, including tamoxifen;
•e) have occasionally used (averaging more than once a week) in the past 30 days the following preparations that may interfere with interpretation of the study results: dehydroepiandrosterone (DHEA) or other drugs or supplements that may, in the opinion of the Investigator, affect sexual function;
•f) have used tablet or powder forms of phytoestrogens for less than 12 weeks prior to Week –4\. Stable use of phytoestrogens for 12 weeks or longer is acceptable, but should be maintained during the study period;
•g) be experiencing any chronic or acute life stress relating to any major life change, such as recent loss of income or the death of a close family member, that may, in the opinion of the Investigator, significantly interfere with sexual activity;
•h) have significant psychiatric disorder (including mild depressive disorder), a significant alcohol or drug dependency and/or be receiving pharmacologic treatment for such illness or disorder. For countries using the Beck Depression Inventory II (BDI\-II), patients will be excluded if they have a score equal or larger than 14\. For Germany, patients will be excluded if they have a score equal or larger than 10 on the BDI\-I;
•i) have current severe dermatological problems (e.g., severe or cystic acne), including concomitant skin disease or history of drug\-induced contact dermatitis;