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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Susan Davis, Monash University
ClinicalTrials.gov Identifier:
NCT00289926
First received: February 9, 2006
Last updated: March 15, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Quality of Life
Menopausal Syndrome
Libido Disorder
Drug: dehydroepiandrosterone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of DHEA treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289926

Locations
Australia, Victoria
Women's Health Research Program, Monash University, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Susan R Davis, MBBS, PhD Monash University
  More Information

Additional Information:
Responsible Party: Professor Susan Davis, Professor of Women's Health, Monash University
ClinicalTrials.gov Identifier: NCT00289926     History of Changes
Obsolete Identifiers: NCT00394342
Other Study ID Numbers: WHP 200501 
Study First Received: February 9, 2006
Last Updated: March 15, 2016
Health Authority: Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Monash University:
low libido
lack of wellbeing

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016