Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-01 @ 10:39 PM
Study NCT ID:
NCT07083635
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}], 'ancestors': [{'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-06', 'size': 173656, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-21T22:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14', 'timeFrame': 'day 14 of treatment', 'description': 'The proportion of study participants who report complete cessation of abnormal vaginal bleeding while receiving the transdermal contraceptive patch treatment and continue to report no vaginal bleeding on day 14 of the 21-day treatment period.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with at least 7 consecutive bleeding-free days during treatment month', 'timeFrame': 'Throughout the treatment month (days 1-21 of treatment)'}, {'measure': 'Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7', 'timeFrame': 'day 7 of treatment'}, {'measure': 'Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21', 'timeFrame': 'day 21 of treatment'}, {'measure': 'Number of days of treatment required before cessation of vaginal bleeding', 'timeFrame': 'From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period'}, {'measure': 'Number of days of spotting/breakthrough bleeding during treatment', 'timeFrame': 'Throughout the 21-day treatment period'}, {'measure': 'Number of days before recurrence of vaginal bleeding after treatment cessation', 'timeFrame': 'From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment'}, {'measure': 'Treatment-related adverse events', 'timeFrame': 'Throughout treatment period (21 days) and follow-up period (3 months post-treatment)'}, {'measure': 'Treatment adherence/compliance', 'timeFrame': 'Throughout the 21-day treatment period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contraceptive implant', 'Abnormal vaginal bleeding', 'Bothersome vaginal bleeding', 'Irregular vaginal bleeding', 'Transdermal hormonal contraception', 'Ethinyl estradiol', 'Norelgestromin', 'Abnormal uterine bleeding', 'Contraceptive-induced bleeding', 'Combined hormonal contraception', 'Hormonal contraceptive patch'], 'conditions': ['Menstruation Disturbances', 'Metrorrhagia', 'Uterine Hemorrhage', 'Contraception Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of transdermal contraceptive patches in treating irregular vaginal bleeding in women over 18 years old who are using contraceptive implants and experiencing abnormal vaginal bleeding. The main questions it aims to answer are:\n\n* Does transdermal ethinyl estradiol and norelgestromin patch effectively treat irregular vaginal bleeding caused by contraceptive implants compared to placebo?\n* What proportion of participants will report cessation of vaginal bleeding during treatment and remain bleeding-free at day 14 of treatment?\n* What is the safety profile and adherence rate of the transdermal patch treatment?\n\nResearchers will compare participants receiving active hormonal patches (ethinyl estradiol 600 mcg + norelgestromin 6 mg) to those receiving placebo patches to see if the hormonal treatment effectively stops irregular vaginal bleeding.\n\nParticipants will:\n\n* Apply transdermal patches for 21 days (changing patch every 7 days - total of 3 patches)\n* Attend follow-up visits at days 7, 14, 21, and 3 months (day 14 in-person, others via telephone)\n* Complete bleeding diaries and report any side effects\n* Follow-up schedule:\n\nDay 7: Telephone follow-up to assess bleeding pattern, side effects, and patch adherence Day 14: In-person visit at the clinic for comprehensive evaluation including bleeding assessment, side effects monitoring, and adherence check Day 21: Telephone follow-up to evaluate treatment completion, ongoing bleeding status, and need for additional treatment 3 months: Final telephone follow-up to assess long-term outcomes and recurrence of bleeding'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years and older\n* Regular menstrual cycles : at least 1 cycle prior to contraceptive implant insertion\n* Normal pelvic examination and transvaginal ultrasound results\n* Normal cervical cancer screening within the past 3 years\n* Irregular vaginal bleeding defined as: Bleeding for more than 8 consecutive days, or Bleeding-free intervals of 15 days or less\n\nExclusion Criteria:\n\n* Previous treatment for irregular vaginal bleeding within the past 3 months\n* Pregnancy\n* Contraindications to estrogen or progestin use\n* Allergy to estrogen or progestin\n* Allergy to hormonal patches\n* Heavy vaginal bleeding causing anemia symptoms such as: Fatigue/Fainting/Dizziness'}, 'identificationModule': {'nctId': 'NCT07083635', 'briefTitle': 'Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial', 'orgStudyIdInfo': {'id': '107/68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Transdermal Hormonal Contraceptive Patch (Ethinyl Estradiol and Norelgestromin)\n\nActive Ingredients:\n\nEthinyl Estradiol: 600 micrograms per patch Norelgestromin: 6 milligrams per patch\n\nAdministration Schedule:\n\n1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)', 'interventionNames': ['Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Transdermal Patch\n\nDetailed Description:\n\nActive Ingredients: None (placebo patch with identical appearance)\n\nAdministration Schedule:\n\n1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)', 'interventionNames': ['Drug: Placebo Patch']}], 'interventions': [{'name': 'Transdermal Ethinyl Estradiol/Norelgestromin Patch', 'type': 'DRUG', 'otherNames': ['Ethinyl Estradiol and Norelgestromin Transdermal Patch', 'Transdermal Contraceptive Patch', 'Combined Hormonal Contraceptive Patch', 'Hormonal Patch'], 'description': 'Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'description': 'Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Pathum Wan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tunchanok Juntamongkol, Doctor of Medicine', 'role': 'CONTACT', 'email': 'tunchanok.junt@gmail.com', 'phone': '+66818084336'}], 'facility': 'Family Planning Clinic, King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'centralContacts': [{'name': 'Tunchanok Juntamongkol, M.D.', 'role': 'CONTACT', 'email': 'tunchanok.junt@gmail.com', 'phone': '+6626494000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tunchanok Juntamongkol, MD', 'investigatorAffiliation': 'Chulalongkorn University'}}}}