Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00796133
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2008-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2008-11-21', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles', 'timeFrame': 'Subjects will remain in the study for approximately 8 months'}], 'secondaryOutcomes': [{'measure': 'Determine with USS and E2 serum levels the dose that can suppress follicle growth and replace estradiol at the physiological early follicular phase level', 'timeFrame': 'Subjects will remain in the study for approximately 8 months'}, {'measure': 'Evaluate the correlation of NES and E2 serum levels with the percentage of ovulation suppression', 'timeFrame': 'Subjects will remain in the study for approximately 8 months'}, {'measure': 'Evaluate the safety and tolerability of the formulations', 'timeFrame': 'Subjects will remain in the study for approximately 8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NES/E2', 'transdermal gel delivery', 'contraception', 'ovulation', 'bleeding patterns'], 'conditions': ['Ovulation']}, 'referencesModule': {'references': [{'pmid': '26032952', 'type': 'DERIVED', 'citation': 'Brache V, Merkatz R, Kumar N, Jesam C, Sussman H, Hoskin E, Roberts K, Alami M, Taylor D, Jorge A, Croxatto H, Lorange E, Mishell DR, Sitruk-Ware R. A dose-finding, cross-over study to evaluate the effect of a Nestorone(R)/Estradiol transdermal gel delivery on ovulation suppression in normal ovulating women. Contraception. 2015 Oct;92(4):289-97. doi: 10.1016/j.contraception.2015.05.011. Epub 2015 May 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman is between 18 and 40 years of age\n* Has intact uterus and ovaries\n* Has regular menstrual cycles of 25-35 days duration\n* Able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic\n* Understands the study procedures and agrees to participate in the study by giving written informed consent\n* Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy\n* Progesterone \\>10 nmol/L in at least one sample in the lead-in cycle\n\nExclusion Criteria:\n\n* All contraindications to OC use including\n* Thrombophlebitis or thromboembolic disorders\n* Past history of deep vein thrombophlebitis or thromboembolic disorders\n* Past or current cerebrovascular or coronary artery disease\n* Known or suspected carcinoma of the breast\n* Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia\n* Undiagnosed abnormal genital bleeding\n* Cholestatic jaundice of pregnancy or jaundice with prior pill use\n* Hepatic adenomas or carcinomas\n* Woman has a history of headaches with focal neurological symptoms\n* Known or suspected pregnancy\n* Aged \\>35 and smoker\n* BMI \\>29\n* Positive urine pregnancy test at the screening or baseline visit\n* Desired pregnancy within the duration of the study\n* Known hypersensitivity to progestins\n* Known hypersensitivity to estrogen\n* Undiagnosed vaginal discharge or vaginal lesions or abnormalities\n* In accordance with the Bethesda system of classification Women with a current abnormal Pap smear suggestive of high-grade pre cancerous lesion(s), including HGSIL, are excluded\n* Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity \\>CIN I is present and/or endocervical curettage is negative\n* Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded if treatment is indicated In accordance with other Pap class systems\n* Women with high grade dysplasia are excluded\n* Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on investigator discretion in accordance with local standard of care\n* Breastfeeding\n* Cancer (past history of any carcinoma or sarcoma)\n* History of a significant psychiatric disorder, including severe depression.\n* Chronic or acute liver or renal disease\n* Hypertension-- controlled by medication or defined by diastolic BP 85 mm Hg or systolic BP 135mm Hg after 15 minutes rest\n* Dermatitis, psoriasis or other severe skin disorder\n* Known or suspected alcoholism or drug abuse\n* Clinically significant abnormalities of laboratory safety tests\n* Chronic disease or history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject\n* Woman is participating or has participated in another clinical study (involving an investigational drug) within one month prior to enrollment.\n* Use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9 months (e.g. DMPA)\n* Use of oral contraceptives within the past 1 month\n* Use of concomitant drugs that may interact with the study drugs'}, 'identificationModule': {'nctId': 'NCT00796133', 'briefTitle': 'A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women', 'organization': {'class': 'OTHER', 'fullName': 'Population Council'}, 'officialTitle': 'A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women', 'orgStudyIdInfo': {'id': 'Population Council #427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '0.5 ml of NES/E2 equaling 0.45 g and contains 1.5 mg NES/0.5 mg E2', 'interventionNames': ['Drug: NES/E2 gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '1.0 ml of NES/E2 gel equaling 0.9 g and contains 3.0 mg NES/1.0 mg E2', 'interventionNames': ['Drug: NES/E2 gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '1.5 ml of NES/E2 gel equaling 4.5 mg NES/1.5 mg E2', 'interventionNames': ['Drug: NES/E2 gel']}], 'interventions': [{'name': 'NES/E2 gel', 'type': 'DRUG', 'description': 'Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P\\<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Women's and Children's Hospital; LA County/USC Medical Center", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto Chileno de Medicina Reproductiva', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Profamilia', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Council', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}