Quality of LifePhase 3NCT00289926
Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms
A Phase 3 study testing dehydroepiandrosterone in people with Quality of Life and Menopausal Syndrome, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Menopausal Syndrome, Libido Disorder
- What is being tested?
- dehydroepiandrosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Show all 14Show fewer
- 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
Who cannot join
- 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?
Show all 20Show fewer
- 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.
- Active malignancy or treatment for malignancy in the preceding 5 years (excluding non-melanotic skin cancer).
- Report alcohol consumption > 3 standard drinks per day.
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Women's Health Research Program, Monash University, The Alfred Hospital
Melbourne, Victoria, 3004
About this study
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
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.
Read the detailed description
Dehydroepiandrosterone (DHEA) and its sulphate (DHEAS) are the most abundant sex steroids in women. Dehydroepiandrosterone sulphate (DHEAS), a unique secretory product of the adrenal gland, and DHEA are converted at various sites in the body, such as the brain, bone and adipose tissue to estrogen or testosterone and their various by-products. DHEAS and DHEA levels decline with age and there has been considerable conjecture that this results in a loss of well-being and libido. DHEA is available as an over-the-counter nutritional supplement in the United States, and is being increasingly prescribed and formulated by compounding pharmacies across Australia. However, there is a paucity of data regarding the effects of oral DHEA on the well-being, sexual function and safety in women. Previous studies evaluating the effects of DHEA on either postmenopausal women or women with adrenal deficiency (Addison's disease) have produced conflicting results, with some studies finding benefit in terms of sexual function and well-being while other studies have found no benefit. Therefore, there is a need for an appropriately powered randomized controlled trial of the effects of DHEA therapy on sexual function and well-being in postmenopausal women. In addition, as DHEA may be metabolized to estrogens, whether DHEA will alleviate vasomotor symptoms merits evaluation. The effects of DHEA on the endometrial (uterine) lining requires assessment, given its potential to be converted to estrogen.
The primary aim of the current study will be to assess the effects of DHEA therapy in naturally menopausal women on sexual function using the Sabbatsberg Self-Rating Scale (SSS) over 12 months in a randomized placebo controlled trial. In addition the effects on well-being will be assessed by the Psychological General Well-Being (PGWB) Index and menopausal symptoms will be evaluated by the Menopause Quality of Life (MENQOL) Intervention Questionnaire. A diary record will also be employed to assess the effects on sexual function. Safety will be assessed over the entire study. Participants will also undergo a transvaginal ultrasound (TVU) at the beginning and end of the study, to determine whether DHEA affects the endometrial lining.
This randomized, double-blind, placebo-controlled study will be conducted in 240 women over a 52-week period. Women will be randomized to receive either placebo or DHEA (50 mg/day) for a 52-week period. It is anticipated that the study will require a 6-month recruitment period. The study duration will be approximately 56 weeks, with a 4-week screening period and treatment period of 52 weeks. The study will be conducted over approximately 13 months. This is a single-centre study and will be conducted at the Alfred Hospital.
Potential participants will be generally healthy women aged 40 - 65 years who have undergone a natural menopause and are in a stable monogamous sexual relationship and not using hormone therapy (HT).
Participants are required to attend 6 clinic visits over a blinded treatment period of 52 weeks. Informed consent will be obtained from the participant prior to the commencement of any study procedure at the first clinic visit. If participants are eligible, they will be asked to return at the end of the screening period to be randomized and commence treatment. During the treatment period, participants will take one capsule daily (placebo or DHEA 50 mg). All participants will return to the clinic 5 more times, at weeks 0, 12, 26, 38 and 52 for assessments of efficacy and safety. Blood tests will be collected at Weeks -4, 0, 12, 26 and 52 to assess safety and hormone levels. Prior to commencing the study, participants will require a mammogram if this has not been done within 12 months of study entry. A transvaginal ultrasound will be performed to assess endometrial thickness prior to commencement of the trial. A Papanicolaou smear will also be performed if the cervix is still present, in those women where a Pap smear has not been done within 12 months of screening. These investigations, except the mammogram and Pap smear, will be repeated at the completion of the study. All participants will have a complete physical examination which will include an assessment of vital signs, breast examination, and internal and external pelvic examination to assess for clitoromegaly (clitoral enlargement). Skin evaluations for scalp hair loss, hirsutism and acne, and assessment for voice changes will be made throughout the study. Participants will be required to complete various questionnaires to assess sexual function (SSS), menopausal symptoms (MENQUOL Intervention) and general well-being (PGWB) at Weeks 0, 12, 26 and 52. Participants will also record satisfactory sexual events in a 28 day diary which will be done in the 4 weeks prior to Weeks 0, 12, 26 and 52.
- Conditions
- Quality of Life, Menopausal Syndrome, Libido Disorder
- Being tested
- dehydroepiandrosterone, placebo
- Keywords
- low libido, lack of wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dehydroepiandrosteroneDrug
Also called DHEA
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
placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| dehydroepiandrosterone | Experimental | 50.0mg dehydroepiandrosterone capsule, by mouth, daily for 12 months Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function
Measured: 6 months
Secondary outcomes (1)
Safety of DHEA treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Susan Davis, Monash University
- Investigators
- Susan R Davis, MBBS, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289926
- Sponsor's protocol ID
- WHP 200501
- Status last verified
- Mar 2016
- First submitted
- 9 Feb 2006
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00289926
- Acronym / sponsor ID
- WHP 200501
- Conditions
- Quality of Life, Menopausal Syndrome, Libido Disorder
- Keywords
- low libido, lack of wellbeing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dehydroepiandrosterone (DHEA) and its sulphate (DHEAS) are the most abundant sex steroids in women. Dehydroepiandrosterone sulphate (DHEAS), a unique secretory product of the adrenal gland, and DHEA are converted at various sites in the body, such as the brain, bone and adipose tissue to estrogen or testosterone and their various by-products. DHEAS and DHEA levels decline with age and there has been considerable conjecture that this results in a loss of well-being and libido. DHEA is available as an over-the-counter nutritional supplement in the United States, and is being increasingly prescribed and formulated by compounding pharmacies across Australia. However, there is a paucity of data regarding the effects of oral DHEA on the well-being, sexual function and safety in women. Previous studies evaluating the effects of DHEA on either postmenopausal women or women with adrenal deficiency (Addison's disease) have produced conflicting results, with some studies finding benefit in terms of sexual function and well-being while other studies have found no benefit. Therefore, there is a need for an appropriately powered randomized controlled trial of the effects of DHEA therapy on sexual function and well-being in postmenopausal women. In addition, as DHEA may be metabolized to estrogens, whether DHEA will alleviate vasomotor symptoms merits evaluation. The effects of DHEA on the endometrial (uterine) lining requires assessment, given its potential to be converted to estrogen.
The primary aim of the current study will be to assess the effects of DHEA therapy in naturally menopausal women on sexual function using the Sabbatsberg Self-Rating Scale (SSS) over 12 months in a randomized placebo controlled trial. In addition the effects on well-being will be assessed by the Psychological General Well-Being (PGWB) Index and menopausal symptoms will be evaluated by the Menopause Quality of Life (MENQOL) Intervention Questionnaire. A diary record will also be employed to assess the effects on sexual function. Safety will be assessed over the entire study. Participants will also undergo a transvaginal ultrasound (TVU) at the beginning and end of the study, to determine whether DHEA affects the endometrial lining.
This randomized, double-blind, placebo-controlled study will be conducted in 240 women over a 52-week period. Women will be randomized to receive either placebo or DHEA (50 mg/day) for a 52-week period. It is anticipated that the study will require a 6-month recruitment period. The study duration will be approximately 56 weeks, with a 4-week screening period and treatment period of 52 weeks. The study will be conducted over approximately 13 months. This is a single-centre study and will be conducted at the Alfred Hospital.
Potential participants will be generally healthy women aged 40 - 65 years who have undergone a natural menopause and are in a stable monogamous sexual relationship and not using hormone therapy (HT).
Participants are required to attend 6 clinic visits over a blinded treatment period of 52 weeks. Informed consent will be obtained from the participant prior to the commencement of any study procedure at the first clinic visit. If participants are eligible, they will be asked to return at the end of the screening period to be randomized and commence treatment. During the treatment period, participants will take one capsule daily (placebo or DHEA 50 mg). All participants will return to the clinic 5 more times, at weeks 0, 12, 26, 38 and 52 for assessments of efficacy and safety. Blood tests will be collected at Weeks -4, 0, 12, 26 and 52 to assess safety and hormone levels. Prior to commencing the study, participants will require a mammogram if this has not been done within 12 months of study entry. A transvaginal ultrasound will be performed to assess endometrial thickness prior to commencement of the trial. A Papanicolaou smear will also be performed if the cervix is still present, in those women where a Pap smear has not been done within 12 months of screening. These investigations, except the mammogram and Pap smear, will be repeated at the completion of the study. All participants will have a complete physical examination which will include an assessment of vital signs, breast examination, and internal and external pelvic examination to assess for clitoromegaly (clitoral enlargement). Skin evaluations for scalp hair loss, hirsutism and acne, and assessment for voice changes will be made throughout the study. Participants will be required to complete various questionnaires to assess sexual function (SSS), menopausal symptoms (MENQUOL Intervention) and general well-being (PGWB) at Weeks 0, 12, 26 and 52. Participants will also record satisfactory sexual events in a 28 day diary which will be done in the 4 weeks prior to Weeks 0, 12, 26 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dehydroepiandrosterone | Experimental | Drug: dehydroepiandrosterone50.0mg dehydroepiandrosterone capsule, by mouth, daily for 12 months |
| Placebo | Placebo comparator | Drug: placeboPlacebo capsule consists of 298.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF manufactured to mimic dehydroepiandrosterone capsule |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dehydroepiandrosteroneAlso: DHEAdehydroepiandrosterone 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 | Drug | dehydroepiandrosterone |
| placeboPlacebo 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 | Drug | Placebo |
Primary outcome
The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function
Time frame: 6 months
1 secondary outcome
Safety of DHEA treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan R Davis, MBBS, PhD principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dehydroepiandrosterone in people with Quality of Life and Menopausal Syndrome, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of the efficacy of oral DHEA therapy in postmenopausal women on sexual function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.