Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve
NCT ID: NCT02268032
Last Updated: 2019-05-29
Study Results
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Basic Information
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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2014-07-15
2016-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Vaginal ring 1 (VRD)
20 women using DHEA (VRD) for 2 menstrual cycles
DHEA
DHEA 2.2 g in vaginal ring
Vaginal ring 2 (VRaA)
20 women using another androgenic agent (VRaA) for 2 menstrual cycles
Another Androgenic Agent (VRaA)
Testosterone 35 mg in vaginal ring
Vaginal ring 3 (VR2A)
20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles
Fixed combination of 2 androgenic agents (VR2A)
DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
Interventions
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DHEA
DHEA 2.2 g in vaginal ring
Another Androgenic Agent (VRaA)
Testosterone 35 mg in vaginal ring
Fixed combination of 2 androgenic agents (VR2A)
DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
Eligibility Criteria
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Inclusion Criteria
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
2. Women with diabetes mellitus
3. Women with untreated or decompensated endocrine disorders
4. Women with a prior history of ovarian surgery or oophorectomy
38 Years
45 Years
FEMALE
Yes
Sponsors
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Laboratorios Andromaco S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Grünenthal Study Director
Role: STUDY_DIRECTOR
Grünenthal GmbH
Locations
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Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile
Santiago, International, Chile
Countries
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References
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Alexander JL, Kotz K, Dennerstein L, Kutner SJ, Wallen K, Notelovitz M. The effects of postmenopausal hormone therapies on female sexual functioning: a review of double-blind, randomized controlled trials. Menopause. 2004 Nov-Dec;11(6 Pt 2):749-65. doi: 10.1097/01.gme.0000142887.31811.97.
Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.
Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
Broekmans FJ, Soules MR, Fauser BC. Ovarian aging: mechanisms and clinical consequences. Endocr Rev. 2009 Aug;30(5):465-93. doi: 10.1210/er.2009-0006. Epub 2009 Jul 9.
Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
Gleicher N, Weghofer A, Barad DH. Improvement in diminished ovarian reserve after dehydroepiandrosterone supplementation. Reprod Biomed Online. 2010 Sep;21(3):360-5. doi: 10.1016/j.rbmo.2010.04.006. Epub 2010 Apr 18.
Pandian Z, McTavish AR, Aucott L, Hamilton MP, Bhattacharya S. Interventions for 'poor responders' to controlled ovarian hyper stimulation (COH) in in-vitro fertilisation (IVF). Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004379. doi: 10.1002/14651858.CD004379.pub3.
Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.
Other Identifiers
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DVR+T001
Identifier Type: -
Identifier Source: org_study_id
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