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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00289926




Registration number
NCT00289926
Ethics application status
Date submitted
9/02/2006
Date registered
10/02/2006
Date last updated
16/03/2016

Titles & IDs
Public title
Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms
Scientific 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
Secondary ID [1] 0 0
WHP 200501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life 0 0
Menopausal Syndrome 0 0
Libido Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dehydroepiandrosterone
Treatment: Drugs - placebo

Experimental: dehydroepiandrosterone - 50.0mg dehydroepiandrosterone capsule, by mouth, daily for 12 months

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


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Safety of DHEA treatment
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Women's Health Research Program, Monash University, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00289926
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan R Davis, MBBS, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries