Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00844012
Status:
UNKNOWN
Last Update Posted:
2009-03-12
First Post:
2009-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of pelvic pain', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Metabolic effects', 'timeFrame': '12 months'}, {'measure': 'Ovarian effects', 'timeFrame': '12 months'}, {'measure': 'Endometrial effects', 'timeFrame': '12 months'}, {'measure': 'Bleedings characteristics', 'timeFrame': '12 months'}, {'measure': 'Protocol adherence', 'timeFrame': '12 months'}, {'measure': 'Satisfaction rate', 'timeFrame': '12 months'}, {'measure': 'Adverse events', 'timeFrame': '12 months'}, {'measure': 'Effects on cognitive function and mood', 'timeFrame': '12 months'}, {'measure': 'Quality of life', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Chronic Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives (OCs) are used with non-contraceptive indication for this disorder.\n\nTo date, OCs are widely used as medical treatment in patients with endometriosis, in addition, they are recently experimented as post-surgical therapy. Traditional cyclic regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually adopted. Furthermore, recent studies suggested that long-term continuous OCs use can be effective in the postoperative period both as second- and third- line treatments after cyclic regimen failure. In these studies a combined treatment with ethinilestradiol (0.02 mg) plus desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate.\n\nA recent study showed a deeper ovarian and endometrial suppression with continuous OCs in comparison with cyclic OCs, providing a physiological rationale for continuous OCs use for noncontraceptive indications. Furthermore, to date, no study compared post-operative continuous versus cyclic OCs in patients with endometriosis-related CPP.', 'detailedDescription': 'Premenopausal women with endometriosis-related CPP scheduled for laparoscopic surgery to our Academic Department of Gynecology will be consecutively enrolled. Subjects with hystologically confirmed endometriosis at laparoscopy (stage I-IV of the American Society Reproductive Medicine), a subjective severity of pelvic pain by using a visual analogue scale (VAS 1-100) of at least 70, and without immediate desire of pregnancy will be enrolled.\n\nBriefly, all patients will undergo conservative laparoscopic surgery for endometriosis. Thereafter, a low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered. Patients from the experimental group will be treated with a continuous regimen, while patients from the control group will receive the OC with a cyclic regimen consisting of 21 days of active pills with 7 days of placebo. The drug and the placebo will be similar and will be labelled according to the subject number. For the overall study-period, operators and patients will be blind to the treatment allocation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal state\n* Endometriosis-related chronic pelvic pain\n* Hystologically confirmed endometriosis at laparoscopy\n* Subjective severity of pelvic pain by using a visual analogue scale of at least 70\n* No immediate desire of pregnancy\n\nExclusion Criteria:\n\n* Age ≤18 or ≥ 40\n* Previous use of drugs for treating CPP (wash-out period of 3 months), with exclusion of non-steroidal anti-inflammatory drugs\n* Contraindication to estro-progestin compounds\n* Major medical diseases\n* Psychiatric disorders\n* Pelvic inflammatory disease\n* Adnexal patologies\n* Unability to complete the daily diary\n* History of alcohol or other drugs abuse'}, 'identificationModule': {'nctId': 'NCT00844012', 'briefTitle': 'Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'Continuous Versus Cyclic Postoperative Use of Low-Dose Combined Oral Contraceptive Belara® for the Treatment of Endometriosis-Related Chronic Pelvic Pain: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '01/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Drug: Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Cyclic OC (clormadinone acetate plus ethinil-estradiol)']}], 'interventions': [{'name': 'Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)', 'type': 'DRUG', 'description': 'Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a continuous regimen.', 'armGroupLabels': ['Experimental group']}, {'name': 'Cyclic OC (clormadinone acetate plus ethinil-estradiol)', 'type': 'DRUG', 'description': 'Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a cyclic regimen.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'contacts': [{'name': 'Fulvio Zullo, MD', 'role': 'CONTACT', 'email': 'zullo@unicz.it', 'phone': '+3909613697180'}, {'name': 'Stefano Palomba, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fulvio Zullo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Catanzaro, Italy', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'centralContacts': [{'name': 'Stefano Palomba, MD', 'role': 'CONTACT', 'email': 'stefanopalomba@tin.it', 'phone': '+39-0961-883234'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fulvio Zullo', 'oldOrganization': 'University Magna Graecia'}}}}