Quality of Life Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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