Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT03091595
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E4/DRSP Ovarian Function Inhibition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C035144', 'term': 'drospirenone'}, {'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-29', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with ovarian inhibition at treatment Cycle 1', 'timeFrame': 'All assessments will be performed once every 3 days starting treatment Cycle 1 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).', 'description': 'Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on:\n\n* the follicular size assessed by transvaginal ultrasound (TVUS)\n* endogenous hormone levels: serum E2, and serum progesterone.'}, {'measure': 'Proportion of subjects with ovarian inhibition at treatment Cycle 3', 'timeFrame': 'All assessments will be performed once every 3 days starting treatment Cycle 3 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).', 'description': 'Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on:\n\n* the follicular size assessed by TVUS\n* endogenous hormone levels: serum E2, and serum progesterone.'}], 'secondaryOutcomes': [{'measure': 'Serum level of luteinizing hormone (LH)', 'timeFrame': 'On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)', 'description': 'Blood samples will be taken at regular time points defined in the time frame.'}, {'measure': 'Serum level of follicle stimulating hormone (FSH)', 'timeFrame': 'On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)', 'description': 'Blood samples will be taken at regular time points defined in the time frame.'}, {'measure': 'Serum level of estradiol (E2)', 'timeFrame': 'On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)', 'description': 'Blood samples will be taken at regular time points defined in the time frame.'}, {'measure': 'Serum level of progesterone (P)', 'timeFrame': 'On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)', 'description': 'Blood samples will be taken at regular time points defined in the time frame.'}, {'measure': 'Maximum endometrial thickness', 'timeFrame': 'From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)', 'description': 'Endometrial thickness will be measured using transvaginal ultrasound (TVUS). Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.'}, {'measure': 'Mean diameter of the largest follicle', 'timeFrame': 'Day 3 to Day 24 of Post-Treatment Cycle', 'description': 'Follicular size will be measured using TVUS.'}, {'measure': 'Number of participants who experience at least one Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 to Follow-Up Visit (+ 30 days)'}, {'measure': 'Number of participants who experience pregnancy during treatment', 'timeFrame': 'Cycle 1 Day 1 to Follow-Up Visit (+ 30 days) (each treatment cycle = 28 days)'}, {'measure': 'Number of participants who experience a clinically significant change in physical examination results', 'timeFrame': 'Day 1 to End of Follow-Up Visit (+ 30 Days)'}, {'measure': 'Number of participants who experience a clinically significant change in gynecological examination results', 'timeFrame': 'Day 1 to End of Follow-Up Visit (+ 30 Days)'}, {'measure': 'Number of participants who experience a clinically significant change in clinical laboratory results', 'timeFrame': 'Day 1 to End of Follow-Up Visit (+ 30 Days)'}, {'measure': 'Number of participants who experience a clinically significant change in electrocardiogram (ECG) results', 'timeFrame': 'Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days)'}, {'measure': 'Number of participants who experience a clinically significant change in echocardiogram results', 'timeFrame': 'Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days)'}, {'measure': 'Change from Baseline in diastolic blood pressure', 'timeFrame': 'From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)'}, {'measure': 'Change from Baseline in systolic blood pressure', 'timeFrame': 'From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)'}, {'measure': 'Change from Baseline in pulse rate', 'timeFrame': 'From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Pregnancy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004267-40/results', 'label': 'Trial results were released to public view on the EudraCT (EudraCT Number: 2016-004267-40).'}]}, 'descriptionModule': {'briefSummary': 'A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Overtly healthy female subjects, as determined by medical history, physical examination including breast examination, gynecological examination (including cervical smear \\[Pap smear\\]), vital signs, ECG, echocardiogram, and laboratory tests.\n* Negative pregnancy test at subject screening.\n* Women who ovulate in the Pre-Treatment Cycle.\n* Willing to use a non-hormonal method of contraception (e.g. condom) during the wash-out period, Pre-Treatment Cycle and Post-Treatment Cycle.\n* BMI between 18.0 and 35.0 kg/m², inclusive, at time of Screening.\n* Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent form (ICF).\n\nExclusion Criteria:\n\n* Irregular menstrual cycle.\n* Amenorrhea or abnormal uterine bleeding.\n* Clinically relevant abnormal laboratory result at Screening.\n* Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound.\n* Known hypersensitivity to any of the investigational or reference product ingredients.\n* Intention to become pregnant during the course of the study.\n* Pregnancy during accurate hormonal contraceptive use in the past.\n* Dyslipoproteinemia requiring active treatment with antilipidemic agent.\n* Diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy, other) or diabetes mellitus of more than 20-year duration.\n* Any arterial hypertension.\n* Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.\n* Complicated valvular heart disease.\n* History of pregnancy-related cardiomyopathy or moderately or severely impaired cardiac function.\n* Systemic lupus erythematosus.\n* Presence or history of migraine with aura.\n* Abnormal Papanicolaou (PAP) smear result.\n* Presence of an undiagnosed breast mass.\n* Current symptomatic gallbladder disease.\n* History of COC-related cholestasis.\n* Presence or history of severe hepatic disease.\n* Presence or history of pancreatitis if associated with hypertriglyceridemia.\n* Porphyria.\n* Presence or history of hepatocellular adenoma or malignant liver tumors.\n* Renal impairment.\n* Hyperkaliemia or presence of conditions that predispose to hyperkaliemia.\n* Presence or history of hormone-related malignancy.\n* History of non-hormone-related malignancy within 5 years before Screening. Subjects with a non-melanoma skin cancer are allowed in the study.\n* Use of drugs potentially triggering interactions with COCs.\n* History of alcohol or drug abuse.\n* Any prior procedure, disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.\n* Uncontrolled thyroid disorders.\n* Have received an investigational drug within the last 2 cycles prior to start of Pre-Treatment Cycle. Subjects who participated in an oral contraceptive clinical study, using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may start the Pre-Treatment Cycle one cycle after last medication intake of the preceding study.\n* Sponsor, contract research organization (CRO) or PI's site personnel directly affiliated with this study.\n* Is judged by the PI to be unsuitable for any reason."}, 'identificationModule': {'nctId': 'NCT03091595', 'briefTitle': 'E4/DRSP Ovarian Function Inhibition Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Estetra'}, 'officialTitle': 'A Single-center, Randomized, Open-label, Two-arm Study to Evaluate the Ovarian Function Inhibition of a Monophasic Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and a Monophasic COC Containing 20mcg Ethinylestradiol (EE)/3 mg DRSP (YAZ®), Administered Orally Once Daily in a 24/4 Day Regimen for Three Consecutive Cycles', 'orgStudyIdInfo': {'id': 'MIT-Es0001-C202'}, 'secondaryIdInfos': [{'id': '2016-004267-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 mg E4/3 mg DRSP', 'description': '15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.', 'interventionNames': ['Drug: 15 mg E4/3 mg DRSP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '20 mcg EE/3 mg DRSP', 'description': '20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.', 'interventionNames': ['Drug: 20 mcg EE/3 mg DRSP']}], 'interventions': [{'name': '15 mg E4/3 mg DRSP', 'type': 'DRUG', 'otherNames': ['15 mg estetrol combined with 3 mg drospirenone'], 'description': '15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles', 'armGroupLabels': ['15 mg E4/3 mg DRSP']}, {'name': '20 mcg EE/3 mg DRSP', 'type': 'DRUG', 'otherNames': ['20 mcg ethinylestradiol combined with 3 mg drospirenone (Yaz)'], 'description': '20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles', 'armGroupLabels': ['20 mcg EE/3 mg DRSP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 CZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Dinox BV', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Christine Klipping', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dinox BV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Estetra', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}