Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02268032
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2014-08-25
Brief Title:
Assess the Effect of Dehydroepiandrosterone DHEA or Other Androgenic Agents Over Markers of Ovarian Reserve
Sponsor:
Laboratorios Andromaco SA
Organization:
Laboratorios Andromaco SA
Study Overview
Official Title:
Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None