Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve

Laboratorios Andromaco

Status and phase: Completed; Phase 1

Conditions: Healthy Women; Infertility, Female

Treatments: Drug: DHEA; Drug: Fixed combination of 2 androgenic agents (VR2A); Drug: Another Androgenic Agent (VRaA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02268032

DVR+T001

Details and patient eligibility

About

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.

Full 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

Enrollment: 94 patients

Sex: Female

Ages: 38 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

94 participants in 3 patient groups

Vaginal ring 1 (VRD)

Experimental group

Description:

20 women using DHEA (VRD) for 2 menstrual cycles

Treatment:

Drug: DHEA

Vaginal ring 2 (VRaA)

Experimental group

Description:

20 women using another androgenic agent (VRaA) for 2 menstrual cycles

Treatment:

Drug: Another Androgenic Agent (VRaA)

Vaginal ring 3 (VR2A)

Experimental group

Description:

20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles

Treatment:

Drug: Fixed combination of 2 androgenic agents (VR2A)