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

• Status: Completed
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Andromaco S.A.
• Treatments: Androgens; Dehydroepiandrosterone

Criteria

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