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

NCT ID: NCT05272930

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-04-30

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.

Detailed Description

Although little is known about the causes of endometriosis, it is reported that women with endometriosis have a high rate of comorbidity with other chronic pain syndromes associated with peripheral and central changes in pain processing, including fibromyalgia, migraine headaches, inflammatory bowel disease, and painful bladder syndrome. Later, various studies conducted in different years showed that cross-organ sensitivity phenomenon, defined as the spread of harmful inputs (inflammation products, mediators, pathogens, etc.) from a diseased visceral organ to a normal organ, comorbidities including IBS, IBD, interstitial cystitis and chronic pelvic pain disorders are common. Therefore, it has been suggested that patients with endometriosis may have a higher risk of developing these chronic diseases. The results of another study are inconsistent with the studies that supports the coexistence of endometriosis and fibromyalgia.

These literature data indicate the need for more data on the frequency of fibromyalgia in women with endometriosis. On the other hand, it has been reported that pain scores are correlated with daily fluctuations of progesterone and testosterone in women with fibromyalgia, and progesterone and testosterone play a protective role for fibromyalgia pain. Dienogest is a fourth-generation selective progestin that has a significant local effect on endometriotic lesions, has little androgenic, less estrogenic, low glucocorticoid or mineralocorticoid activity and minimal effect on metabolic parameters, and is used in the medical treatment of endometriosis. However, there is no data on the effects of hormonal therapy used in the treatment of endometriosis on the frequency and severity of symptoms of fibromyalgia associated with endometriosis. Therefore, in this study, it was aimed to evaluate the effects of progesterone therapy used in endometriosis patients on fibromyalgia frequency, fibromyalgia severity and quality of life.

Conditions

Fibromyalgia; Endometriosis Ovary; Dienogest

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Dienogest

Assessment of fibromyalgia effects after the use of dienogest

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatma Ketenci Gencer, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpaşaTREHh

Identifier Type: -

Identifier Source: org_study_id