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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02268032
Study type Interventional
Source Laboratorios Andromaco S.A.
Contact
Status Completed
Phase Phase 1
Start date July 15, 2014
Completion date August 31, 2016

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