Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve
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|ClinicalTrials.gov Identifier: NCT02268032|
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Women Infertility, Female||Drug: DHEA Drug: Another Androgenic Agent (VRaA) Drug: Fixed combination of 2 androgenic agents (VR2A)||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve|
|Actual Study Start Date :||July 15, 2014|
|Actual Primary Completion Date :||August 31, 2016|
|Actual Study Completion Date :||August 31, 2016|
Experimental: Vaginal ring 1 (VRD)
20 women using DHEA (VRD) for 2 menstrual cycles
DHEA 2.2 g in vaginal ring
Experimental: Vaginal ring 2 (VRaA)
20 women using another androgenic agent (VRaA) for 2 menstrual cycles
Drug: Another Androgenic Agent (VRaA)
Testosterone 35 mg in vaginal ring
Experimental: Vaginal ring 3 (VR2A)
20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles
Drug: Fixed combination of 2 androgenic agents (VR2A)
DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268032
|Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile|
|Santiago, International, Chile, 7501257|
|Study Director:||Grünenthal Study Director||Grünenthal GmbH|