The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis

NCT05272930 | Completed FDA Drug

• 1 other identifier: GaziosmanpaşaTREHh
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Endometriosis Ovary; Dienogest

Outcome Measures

Primary Outcomes (3)

• Determination of recovery rate of participants diagnosed as in terms of fibromyalgia symptoms after dienogest use by using Visual Analog Scale (VAS).

  VAS is a 10 cm labeled "No Pain" on one end and "The Most Severe Pain Possible" on the other. On a long line, the participant is asked to mark a point on this line that corresponds to the intensity of pain she feels. The distance between the starting point expressed as "No Pain" and the marked point is measured with a ruler and recorded in centimeters.

  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.

  The first section contains 3 questions about fatigue, cognitive problems, and sleep symptoms, each scored in a likert format from 0 (no problem) to 3 (severe: persistent, life-disturbing problems) over the past week. The second part consists of 3 questions (maximum score 3) that give positive or negative answers to the following somatic complaints that have arisen in the last 6 months; abdominal pain or cramps, depression and headache. The sum of Parts 1 and 2 provides a Symptom Severity (SS) Score in the range of 0-12.

  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

  The third section is a measurement of the Widespread Pain Index (WPI) and is completed by identifying body areas where pain or tenderness has been felt during the previous 7 days. The maximum score for the WPI section is 19. Polysymptomatic distress (PSD) is defined as the sum of the (0-19) WPI and the 6-item (0-12) SS scale, ranging from 0-31.

  6 months

Interventions

Dienogest DRUG

Assessment of fibromyalgia effects after the use of dienogest

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who applied to Gaziosmanpasa Training and Research Hospital Gynecology and Obstetrics Polyclinic, previously diagnosed with fibromyalgia and diagnosed with unilateral endometrioma.

You may qualify if:

• years old
• Nulliparity
• Women diagnosed with endometrioma (unilateral, ≤ 4cm) by physical examination and vaginal/transabdominal ultrasonography

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

dienogest

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 10, 2022
• Study Start: June 30, 2021
• Primary Completion: March 15, 2022
• Study Completion: April 30, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)