Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing a… (NCT00289926) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms
Australia240 participantsStarted 2006-02
Plain-language summary
This study is designed to evaluate the efficacy and safety of oral Dehydroepiandrosterone (DHEA) 50mg daily, for 12 months in naturally menopausal women with low libido who are not receiving systemic oestrogen or oestrogen- progestin therapy.
Efficacy measures for the present study are effects on sexual function, wellbeing and menopausal symptoms. Safety measures will include endometrial assessment by transvaginal ultrasound (TVU), vital signs, lipid profiles, general electrolytes, effects on glucose metabolism and reports of adverse events.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. are 40 to 65 years of age, at least 12 months postmenopausal (no spontaneous menses in the last 12 months, or be over the age of 55 years, or hysterectomy with one or both ovaries in situ and follicle-stimulating hormone \[FSH\] \> 20 IU/L. (An FSH \> 20 IU/L will also be used to confirm menopausal status in non-hysterectomised women \< 55 years, where menopausal status is unclear.)
. are sexually active -defined as being involved in any form of sexual activity at least once a month. Women do not require a partner.
. have a body mass index (BMI) 18-34 kg/m2.
. answer affirmatively to the following questions:
. Have a clinically acceptable screening bilateral mammogram
. Have ≤ 4 mm endometrial double thickness and no other abnormal findings on TVU if not hysterectomised.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function
. Have a clinically acceptable Pap smear if the cervix is present,
. Be able and willing to participate in the study as evidenced by providing written informed consent.
Exclusion criteria
. Have a BMI \< 18 or \> 34 kg/m2
. Dyspareunia not alleviated by use of lubricants.
. Severe depression (Beck Depression Inventory Score-II \[BDI\] \> 20).
. Have partnership problems. This will be established by interview by asking the following questions if a woman is in a specific relationship:
. Are you satisfied with your partner as a friend?
. Do you have concerns about your relationship?
. Have used recent androgen therapy (testosterone implant within the last 28 weeks, transdermal testosterone cream within the last 8 weeks, tibolone within the last 12 weeks, oral testosterone within the last 4 weeks and injected testosterone within the last 6 weeks).
. Have used treatment for depression (antidepressants, antipsychotics, antiepileptics) within 2 months ).