Clinical trial

The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis: A Cross-sectional Observational Study.

Name
GaziosmanpaşaTREHh
Description
Endometriosis usually occurs during the reproductive period of women and poses a significant burden on quality of life and social costs. The estimated prevalence in premenopausal women is 10% in clinical studies and the frequency rises to 50% in symptomatic patients with pelvic pain and infertility. Observational studies in Europe estimated the prevalence to be 8-15 per 1000 people. Fibromyalgia is a common musculoskeletal chronic painful condition that may be accompanied by cognitive impairment, somatic symptoms, fatigue, and psychiatric symptoms. The population frequency is given as 20-80 per 1000 people. Fibromyalgia is most often diagnosed in women aged 20-55 years; prevalence increases with age and is associated with a higher prevalence of comorbidities, including endocrine and genitourinary disorders. Co-existance of endometriosis and fibromyalgia is a special entity that has not been enlightened in detal yet.
Trial arms
Trial start
2021-06-30
Estimated PCD
2022-03-15
Trial end
2022-04-30
Status
Completed
Treatment
Dienogest
Assessment of fibromyalgia effects after the use of dienogest
Size
61
Primary endpoint
Determination of recovery rate of participants diagnosed as in terms of fibromyalgia symptoms after dienogest use by using Visual Analog Scale (VAS).
6 months
Determination of recovery rate of Symptom Severity (SS) Score in participants in terms of fibromyalgia symptoms after dienogest use by using Fibromyalgia Questionnaire Diagnostic Criteria and Symptom Severity Scale.
6 months
Determination of recovery rate of Widespread Pain Index (WPI) Score in participants in terms of fibromyalgia symptoms after dienogest use by using Fibromyalgia Questionnaire Diagnostic Criteria and Symptom Severity Scale
6 months
Eligibility criteria
Inclusion Criteria: * 18 - 40 years old * Nulliparity * Women diagnosed with endometrioma (unilateral, ≤ 4cm) by physical examination and vaginal/transabdominal ultrasonography Exclusion Criteria: * Pelvic mass that cannot be differentially diagnosed by physical examination and imaging techniques * Endometrioma cases with surgical treatment indication * Any concurrent major psychiatric disorder * Any medical condition that may interfere with sensory perception (diabetes, neurological disorder, etc.) * Presence of any other concomitant painful condition other than fibromyalgia and endometriosis * Currently using any hormonal therapy * History and/or presence of malignancy * Pregnancy * Menopause or premature ovarian failure
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}
Updated at
2023-02-23

1 organization

1 product

3 indications

Product
Dienogest
Indication
Fibromyalgia
Indication
Endometriosis
Indication
Dienogest