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Trial record 76 of 1542 for:    Androgens

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
Sponsor:
Information provided by (Responsible Party):
Laboratorios Andromaco S.A.

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.

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

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Vaginal ring 1 (VRD)
20 women using DHEA (VRD) for 2 menstrual cycles
Drug: DHEA
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   38 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Women with preserved menstrual cycles.
  3. Women smoking less than 5 cigarettes daily.
  4. Anti-Müllerian hormone (AMH) between 0.5-1.1 ng/mL
  5. Total antral follicle count (AFC) 5-7

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Chile
Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile
Santiago, International, Chile, 7501257
Sponsors and Collaborators
Laboratorios Andromaco S.A.
Investigators
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Study Director: Grünenthal Study Director Grünenthal GmbH

Publications:

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Responsible Party: Laboratorios Andromaco S.A.
ClinicalTrials.gov Identifier: NCT02268032     History of Changes
Other Study ID Numbers: DVR+T001
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Laboratorios Andromaco S.A.:
Hormone replacement therapy
Additional relevant MeSH terms:
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Androgens
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists