FibromyalgiaNCT05272930
The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis
An observational study of Fibromyalgia and Endometriosis Ovary, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fibromyalgia, Endometriosis Ovary, Dienogest
- What is being tested?
- Dienogest
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who applied to Gaziosmanpasa Training and Research Hospital Gynecology and Obstetrics Polyclinic, previously diagnosed with fibromyalgia and diagnosed with unilateral endometrioma.
Who may be able to join
- 18 - 40 years old
- Nulliparity
- Women diagnosed with endometrioma (unilateral, ≤ 4cm) by physical examination and vaginal/transabdominal ultrasonography
Who cannot join
- 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
Show all 9Show fewer
- History and/or presence of malignancy
- Pregnancy
- Menopause or premature ovarian failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis: A Cross-sectional Observational Study.
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.
Read the 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
- Being tested
- Dienogest
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Assessment of fibromyalgia effects after the use of dienogest
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start30 Jun 2021
- Primary completion15 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Ketenci Gencer, MD, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272930
- Sponsor's protocol ID
- GaziosmanpaşaTREHh
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis: A Cross-sectional Observational Study.
- ClinicalTrials.gov ID
- NCT05272930
- Acronym / sponsor ID
- GaziosmanpaşaTREHh
- Conditions
- Fibromyalgia, Endometriosis Ovary, Dienogest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who applied to Gaziosmanpasa Training and Research Hospital Gynecology and Obstetrics Polyclinic, previously diagnosed with fibromyalgia and diagnosed with unilateral endometrioma.
Key inclusion criteria (3 listed)
- 18 - 40 years old
- Nulliparity
- Women diagnosed with endometrioma (unilateral, ≤ 4cm) by physical examination and vaginal/transabdominal ultrasonography
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DienogestAssessment of fibromyalgia effects after the use of dienogest | Drug | – |
Primary outcome
Determination of recovery rate of participants diagnosed as in terms of fibromyalgia symptoms after dienogest use by using Visual Analog Scale (VAS).
Time frame: 6 months
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.
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.
Time frame: 6 months
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.
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
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Endometriosis Ovary, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of recovery rate of participants diagnosed as in terms of fibromyalgia symptoms after dienogest use by using Visual Analog Scale (VAS). (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.