Skip to main content
OpenTrials
Completed

NCT Number: NCT02268032

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Women Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

38 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile

Santiago, International, 7501257, Chile

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Women with preserved menstrual cycles.
  • Women smoking less than 5 cigarettes daily.
  • Anti-Müllerian hormone (AMH) between 0.5-1.1 ng/mL
  • Total antral follicle count (AFC) 5-7

Exclusion criteria

  • Women receiving medications that interact with DHEA metabolism (Anastrozole, exemestane, Fulvestrant, Insulin, Letrozole, Tamoxifen, Triazolam).
  • Women with diabetes mellitus
  • Women with untreated or decompensated endocrine disorders
  • Women with a prior history of ovarian surgery or oophorectomy

Treatment and study plan

DHEA

Drug

DHEA 2.2 g in vaginal ring

Another Androgenic Agent (VRaA)

Drug

Testosterone 35 mg in vaginal ring

Fixed combination of 2 androgenic agents (VR2A)

Drug

DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring

Primary outcomes

  1. Effect of the association of DHEA plus testosterone over ovarian reserve markers

    Time frame: 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 outcomes

  1. 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

    Time frame: Before therapy start and up to 2 months thereafter

    A composite of hormones was measured and compared before and after hormonal therapy.

  2. Tolerability of using the vaginal ring

    Time frame: 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).

  3. Number of subjects with adverse events per treatment group

    Time frame: From therapy start to up to 2 months

    Adverse events were collected by non-leading questions.

Sponsors and collaborators

Lead sponsor

Laboratorios Andromaco S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.