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

NCT00289926 | Completed Phase 3 DMC

• 1 other identifier: WHP 200501
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Menopausal Syndrome; Libido Disorder

Keywords

low libido; lack of wellbeing

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• Safety of DHEA treatment

  12 months

Study Arms (2)

dehydroepiandrosterone

EXPERIMENTAL

50.0mg dehydroepiandrosterone capsule, by mouth, daily for 12 months

Drug: dehydroepiandrosterone

Placebo

PLACEBO COMPARATOR

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

Interventions

dehydroepiandrosterone DRUG

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

Also known as: DHEA

dehydroepiandrosterone

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who:
• 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:
• 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?
• 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.
• have a baseline DHEAS level of \< 2.1 umol/L

You may not qualify if:

• 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 ).
• Have known severe psychiatric illness.
• 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.)
• 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.)
• Have renal disease, liver disease, epilepsy, or diabetes mellitus or any other major illness that has occurred within the last 6 months.
• Therapies known to induce liver enzyme metabolism or alter the metabolism of DHEA e.g. antiepileptics, dexamethasone, or antituberculous drugs.
• Undiagnosed genital bleeding.
• Have moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, or have androgenic alopecia.

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Women's Health Research Program, Monash University, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Women's Health research Program

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Susan R Davis, MBBS, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Women's Health

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 16, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)