Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Monash University
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

Women who:

1. 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.)

2. are sexually active -defined as being involved in any form of sexual activity at least once a month. Women do not require a partner.

3. have a body mass index (BMI) 18-34 kg/m2.

4. answer affirmatively to the following questions:

• In previous years did you find sexual activity satisfying?

• Do you feel that you have experienced a significant decrease in your desire or interest?

• Would you like an improvement in your desire or interest for sexual activity?

• Would you like to be treated for this?

5. Have a clinically acceptable screening bilateral mammogram

6. Have ≤ 4 mm endometrial double thickness and no other abnormal findings on TVU if not hysterectomised.

7. Have a clinically acceptable Pap smear if the cervix is present,

8. Be able and willing to participate in the study as evidenced by providing written informed consent.

9. have a baseline DHEAS level of < 2.1 umol/L

Exclusion Criteria:

1. Have a BMI < 18 or > 34 kg/m2

2. Dyspareunia not alleviated by use of lubricants.

3. Severe depression (Beck Depression Inventory Score-II [BDI] > 20).

4. Have partnership problems. This will be established by interview by asking the following questions if a woman is in a specific relationship:

1. Are you satisfied with your partner as a friend?

2. Do you have concerns about your relationship?

5. 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).

6. Have used treatment for depression (antidepressants, antipsychotics, antiepileptics) within 2 months ).

7. Have known severe psychiatric illness.

8. Have used estrogen, including vaginal conjugated equine estrogen, vaginal ring delivering up to 7.5 µg/day, or estrogen-progestin combinations in the last 2 months. (Use of Ovestin or Vagifem pessaries or cream will be allowed.)

9. Used phytoestrogens within 1 week prior to Week -4 (Visit 1). (Women will be allowed to participate in this trial, provided they cease using phytoestrogens for at least 1 week before visit 1.)

10. Have renal disease, liver disease, epilepsy, or diabetes mellitus or any other major illness that has occurred within the last 6 months.

11. Therapies known to induce liver enzyme metabolism or alter the metabolism of DHEA e.g. antiepileptics, dexamethasone, or antituberculous drugs.

12. Undiagnosed genital bleeding.

13. Have moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, or have androgenic alopecia.

14. Active malignancy or treatment for malignancy in the preceding 5 years (excluding non-melanotic skin cancer).

15. Report alcohol consumption > 3 standard drinks per day.

16. Have a history of cerebrovascular disease, thromboembolic disorders, myocardial infarction or angina at anytime before study entry or thrombophlebitis within the last 5 years.

16. An abnormal thyroid-stimulating hormone (TSH) value at screening (however, participants with an abnormal TSH, but normal free T4 and free T3 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study).

17. Have abnormal liver function (LFTs) which is significant and/or an ALT or AST > 3 times the upper limit of normal or bilirubin > 2 times the upper limit of normal.