Status:
COMPLETED
Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Healthy Women
Infertility, Female
Eligibility:
FEMALE
38-45 years
Phase:
PHASE1
Brief 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 r...
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 present...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT02268032
Start Date
July 15 2014
End Date
August 31 2016
Last Update
May 29 2019
Active Locations (1)
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1
Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile
Santiago, International, Chile, 7501257