Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 2:36 AM
Study NCT ID:
NCT01087593
Status:
TERMINATED
Last Update Posted:
2010-03-16
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Due to ethical concerns regard to the results from the WHI study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-09', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-15', 'studyFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain thresholds and pain tolerance', 'timeFrame': 'Before and after eight weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['estrogen', 'substitution', 'pain', 'hormonal levels', 'quantitative sensory testing'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '21078629', 'type': 'DERIVED', 'citation': 'Stening KD, Eriksson O, Henriksson KG, Brynhildsen J, Lindh-Astrand L, Berg G, Hammar M, Amandusson A, Blomqvist A. Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial. Rheumatology (Oxford). 2011 Mar;50(3):544-51. doi: 10.1093/rheumatology/keq348. Epub 2010 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'In order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.', 'detailedDescription': 'Fibromyalgia is a condition that preferentially affects women. Sex hormones, and in particular estrogens, have been shown to affect pain processing and pain sensitivity, and estrogen deficit has been considered a potential promoting factor for fibromyalgia. However, the effects of estrogen treatment in patients suffering from fibromyalgia have not been studied. Twenty-nine postmenopausal women were randomized to either eight weeks of treatment with transdermal 17β-estradiol (50 ug daily) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed at three occasions: before treatment, after eight weeks of treatment, and twenty weeks after cessation of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 49-60 years\n* Body mass index (BMI) of \\< 30\n* Met the ACR-90 criteria for the diagnosis of fibromyalgia\n* Postmenopausal state since at least six months\n* Not been using any hormonal treatments for the past three months\n* Had normal mammography screenings\n\nExclusion Criteria:\n\n* Using psychotropic drugs or having a history of thromboembolism\n* Diabetes mellitus, polyneuropathy, chronic liver disease,\n* Alcohol or substance abuse, hemoglobinopathy,\n* Endometrial adenomatous hyperplasia, or malignancy.\n* Presence of untreated hypertension (\\>160/95).\n* Undiagnosed vaginal bleedings'}, 'identificationModule': {'nctId': 'NCT01087593', 'briefTitle': 'Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Ostergotland County Council, Sweden'}, 'officialTitle': 'Hormonal Replacement Therapy Does Not Affect Self-estimated Pain or Experimental Pain Responses in Postmenopausal Women Suffering From Fibromyalgia: A Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '151 662/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with transdermal 17β-estradiol', 'interventionNames': ['Drug: 17β-estradiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: 17β-estradiol']}], 'interventions': [{'name': '17β-estradiol', 'type': 'DRUG', 'otherNames': ['Evorel', 'provera'], 'description': 'Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks', 'armGroupLabels': ['Control', 'Treatment with transdermal 17β-estradiol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'University hospital in Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Mats Hammar, MD, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Linkoeping'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ostergotland County Council, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mats Hammar', 'oldOrganization': 'Ostergotland County Council'}}}}