2268032
Last Update Posted: 2019-05-29
Recruiting has ended
Females accepted | 38 Years-45 Years |
94 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
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.
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
Eligibility
Relevant conditions:
Healthy Women
Infertility, Female
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov