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 range40 Years – 65 Years

SexFEMALE

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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.
✓. 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

What they're measuring

The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function

Timeframe: 6 months

Trial details

NCT IDNCT00289926

SponsorMonash University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

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