NCT02268032

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

Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: Female
• Age: 38 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Women
• Infertility, Female

Interventions

Type	Name	Description
DRUG	DHEA	DHEA 2.2 g in vaginal ring
DRUG	Another Androgenic Agent (VRaA)	Testosterone 35 mg in vaginal ring
DRUG	Fixed combination of 2 androgenic agents (VR2A)	DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring

Timeline

• Start date: 2014-07-15
• Primary completion: 2016-08-31
• Completion: 2016-08-31
• First posted: 2014-10-20
• Last updated: 2019-05-29

Locations

1 site across 1 country: Chile