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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05272930
• Other study ID #: GaziosmanpasaTREHh
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2023
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 30, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Ovary
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Dienogest
Assessment of fibromyalgia effects after the use of dienogest

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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