Healthy Women, Infertility, Female
Conditions
Keywords
Hormone replacement therapy
Brief summary
This study was conducted to evaluate the effect of a continuous administration of dehydroepiandrosterone (DHEA) or other androgenic agents on ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral follicle count (AFC) and anti-Müllerian hormone (AMH) concentrations.
Detailed description
Healthy women attending the clinic of the Mother and Health Research Institute (IDIMI) were invited to participate, if they could not become pregnant due to surgical sterilization, and if they presented no contraindications to use androgen therapy. Project Objectives : The general objective was to evaluate pharmacokinetic parameters of three vaginal rings containing DHEA, testosterone, or combination of both hormones in women. Secondary objectives were to assess effects on the hormonal profile, tolerability and incidence of adverse events. * DHEA and/or, testosterone levels * Estradiol, follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), androstenedione, morning cortisol, insulin growth factor 1 (IGF-1) levels * Tolerability and safety assessment by the use of the vaginal ring. * The incidence of adverse events
Interventions
DRUGDHEA
DHEA 2.2 g in vaginal ring
DRUGAnother Androgenic Agent (VRaA)
Testosterone 35 mg in vaginal ring
DRUGFixed combination of 2 androgenic agents (VR2A)
DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
Sponsors
Laboratorios Andromaco S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women between 38 and 45 years of age who have not used hormonal contraceptive methods at least for the past two months, or who have been surgically sterilized, with no contraindications for androgenic therapy. 2. Women with preserved menstrual cycles. 3. Women smoking less than 5 cigarettes daily. 4. Anti-Müllerian hormone (AMH) between 0.5-1.1 ng/mL 5. Total antral follicle count (AFC) 5-7
Exclusion criteria
1. Women receiving medications that interact with DHEA metabolism (Anastrozole, exemestane, Fulvestrant, Insulin, Letrozole, Tamoxifen, Triazolam). 2. Women with diabetes mellitus 3. Women with untreated or decompensated endocrine disorders 4. Women with a prior history of ovarian surgery or oophorectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the association of DHEA plus testosterone over ovarian reserve markers | Before therapy start and up to 2 months thereafter | The ovarian reserve markers antral follicle count (AFC) and anti-Müllerian hormone (AMH) were determined before and after hormonal therapy to compare the levels of both hormones between mono- and combination therapy and to investigate a potentially synergistic effect of the association of DHEA plus testosterone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of sex hormone binding globulin (SHBG), androstenedione, morning cortisol, insulin growth factor 1 (IGF-1), testosterone, dehydroepiandrosterone, follicle stimulating hormone (FSH), and estradiol | Before therapy start and up to 2 months thereafter | A composite of hormones was measured and compared before and after hormonal therapy. |
| Tolerability of using the vaginal ring | After therapy start (vaginal ring insertion) and after 2 months (ring extraction) | A questionnaire was used post insertion and post extraction of the vaginal ring to assess tolerability. The following was addressed: changes in vaginal discharge (never happened/no change/increased a little/increased much/changed color), vaginal infection (by fungi or bacteria: yes/no), burning (yes/no), odor (yes/no), pain (yes/no; if yes, assessed on a 1 to 10 scale for no pain to worst pain), discomfort (yes/no) or dryness (yes/no) of the vagina, changes (for couples) in the sexual relationship by the use of the vaginal ring (better/as always/with annoyance/with pain/did not have). |
| Number of subjects with adverse events per treatment group | From therapy start to up to 2 months | Adverse events were collected by non-leading questions. |
Countries
Chile
Outcome results
None listed