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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289926
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Professor Susan Davis, Monash University

Brief 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.

Condition or disease Intervention/treatment Phase
Quality of Life Menopausal Syndrome Libido Disorder Drug: dehydroepiandrosterone Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms
Study Start Date : February 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Experimental: dehydroepiandrosterone
50.0mg dehydroepiandrosterone capsule, by mouth, daily for 12 months
Drug: dehydroepiandrosterone
dehydroepiandrosterone capsules 50.0 mg /capsule DHEA 248.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule
Other Name: DHEA

Placebo Comparator: Placebo
Placebo capsule consists of 298.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF manufactured to mimic dehydroepiandrosterone capsule
Drug: placebo
Placebo capsules of 298.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule manufactured to mimic the active DHEA capsule

Primary Outcome Measures :
  1. The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety of DHEA treatment [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289926

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Australia, Victoria
Women's Health Research Program, Monash University, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
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Principal Investigator: Susan R Davis, MBBS, PhD Monash University
Additional Information:
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Responsible Party: Professor Susan Davis, Professor of Women's Health, Monash University Identifier: NCT00289926    
Obsolete Identifiers: NCT00394342
Other Study ID Numbers: WHP 200501
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Professor Susan Davis, Monash University:
low libido
lack of wellbeing
Additional relevant MeSH terms:
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Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs