Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT00338312
Eligibility Criteria:
Inclusion Criteria:
Eligible women must:
1. Be 40-70 years old and in generally good health
2. Be post-menopausal with no spontaneous periods for 1 year
3. Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
4. 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
5. Meet the criteria for having hypoactive sexual desire disorder
Exclusion Criteria:
Eligible women must not:
1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
7. 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
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00338312
Study Brief:
Protocol Section:
NCT00338312