Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-04-03 @ 11:40 PM
Study NCT ID:
NCT02268032
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2014-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of the association of DHEA plus testosterone over ovarian reserve markers', 'timeFrame': 'Before therapy start and up to 2 months thereafter', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Before therapy start and up to 2 months thereafter', 'description': 'A composite of hormones was measured and compared before and after hormonal therapy.'}, {'measure': 'Tolerability of using the vaginal ring', 'timeFrame': 'After therapy start (vaginal ring insertion) and after 2 months (ring extraction)', 'description': '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).'}, {'measure': 'Number of subjects with adverse events per treatment group', 'timeFrame': 'From therapy start to up to 2 months', 'description': 'Adverse events were collected by non-leading questions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hormone replacement therapy'], 'conditions': ['Healthy Women', 'Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '15543027', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16997936', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16517559', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19589949', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19054777', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21505041', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20638339', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20091563', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20729538', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nProject Objectives :\n\nThe general objective was to evaluate pharmacokinetic parameters of three vaginal rings containing DHEA, testosterone, or combination of both hormones in women.\n\nSecondary objectives were to assess effects on the hormonal profile, tolerability and incidence of adverse events.\n\n* DHEA and/or, testosterone levels\n* Estradiol, follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), androstenedione, morning cortisol, insulin growth factor 1 (IGF-1) levels\n* Tolerability and safety assessment by the use of the vaginal ring.\n* The incidence of adverse events'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. Women with preserved menstrual cycles.\n3. Women smoking less than 5 cigarettes daily.\n4. Anti-Müllerian hormone (AMH) between 0.5-1.1 ng/mL\n5. Total antral follicle count (AFC) 5-7\n\nExclusion Criteria:\n\n1. Women receiving medications that interact with DHEA metabolism (Anastrozole, exemestane, Fulvestrant, Insulin, Letrozole, Tamoxifen, Triazolam).\n2. Women with diabetes mellitus\n3. Women with untreated or decompensated endocrine disorders\n4. Women with a prior history of ovarian surgery or oophorectomy'}, 'identificationModule': {'nctId': 'NCT02268032', 'briefTitle': 'Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Andromaco S.A.'}, 'officialTitle': 'Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve', 'orgStudyIdInfo': {'id': 'DVR+T001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal ring 1 (VRD)', 'description': '20 women using DHEA (VRD) for 2 menstrual cycles', 'interventionNames': ['Drug: DHEA']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal ring 2 (VRaA)', 'description': '20 women using another androgenic agent (VRaA) for 2 menstrual cycles', 'interventionNames': ['Drug: Another Androgenic Agent (VRaA)']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal ring 3 (VR2A)', 'description': '20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles', 'interventionNames': ['Drug: Fixed combination of 2 androgenic agents (VR2A)']}], 'interventions': [{'name': 'DHEA', 'type': 'DRUG', 'description': 'DHEA 2.2 g in vaginal ring', 'armGroupLabels': ['Vaginal ring 1 (VRD)']}, {'name': 'Another Androgenic Agent (VRaA)', 'type': 'DRUG', 'description': 'Testosterone 35 mg in vaginal ring', 'armGroupLabels': ['Vaginal ring 2 (VRaA)']}, {'name': 'Fixed combination of 2 androgenic agents (VR2A)', 'type': 'DRUG', 'description': 'DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring', 'armGroupLabels': ['Vaginal ring 3 (VR2A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7501257', 'city': 'Santiago', 'state': 'International', 'country': 'Chile', 'facility': 'Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Grünenthal Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Grünenthal GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Andromaco S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}