EndometriosisNCT04816357
Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study
An observational study of Endometriosis and Migraine, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Endometriosis, Migraine
- What is being tested?
- Questionaire
- How many people
- 344 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Mar 2021to 4 Nov 2021
- How long will I take part?
- 1 Day
- 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 99 years
- Women only
- Adult, Older adult
Study population: From our database of operated endometriosis patients ranging from 2016-2020 100 women will be identified within the first phone call as cases with endometriosis and migraine and the threefold number (n=300) as control with endometriosis only.
Who may be able to join
- Premenopausal women aged 18-55 years, at time of operation
- Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
- For the cases migraine needs to be confirmed during the interview according to the IHS criteria.
Who cannot join
- Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation.
Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted as well as response to Dienogest treatment.
In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).
- Conditions
- Endometriosis, Migraine
- Being tested
- Questionaire
- Medical subject headings
- Endometriosis, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
only questionaire
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis & Migraine | * Premenopausal women aged 18-55 years, at time of operation
* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
* For the cases migraine needs to be confirmed during the interview according to the IHS criteria. Receives: Other: Questionaire | |
| Endometriosis | * Premenopausal women aged 18-55 years, at time of operation
* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available) Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis stage
endometriosis stage confirmed by laparascopy compared to the control group
Measured: 4 years
Secondary outcomes (5)
infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations
s.o.
Measured: 4 years
and age of first symptoms for both conditions and age at first operation
s.o.
Measured: 4 years
family history with first-degree relatives,
s.o.
Measured: 4 years
Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response,
s.o.
Measured: 4 years
response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted
s.o.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start25 Mar 2021
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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-control
- Time perspective
- Other
- Enrolment
- 344 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Dietrich, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816357
- Sponsor's protocol ID
- 2021-00285
- Status last verified
- Feb 2022
- First submitted
- 22 Mar 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dietrich H, Knobel C, Portmann L, Metzler J, Muendane A, Niggli A, Neumeier MS, Imesch P, Merki-Feld GS. Endometriosis features and dienogest tolerability in women with depression: a case-control study. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):198-204. doi: 10.1080/13625187.2023.2199899. Epub 2023 May 3.
PubMed 37132337Neumeier MS, Pohl H, Dietrich H, Knobel C, Portmann L, Metzler J, Imesch P, Merki-Feld GS. Endometriosis Features in Women With and Without Migraine. J Womens Health (Larchmt). 2023 May;32(5):598-607. doi: 10.1089/jwh.2022.0359. Epub 2023 Mar 10.
PubMed 36897310
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study
- ClinicalTrials.gov ID
- NCT04816357
- Acronym / sponsor ID
- 2021-00285
- Conditions
- Endometriosis, Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 25 Mar 2021 (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.
Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation.
Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted as well as response to Dienogest treatment.
In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis & Migraine | – | Other: Questionaire* Premenopausal women aged 18-55 years, at time of operation * Endometriosis confirmed with surgery and histologic staging (Report of the surgery available) * For the cases migraine needs to be confirmed during the interview according to the IHS criteria. |
| Endometriosis | – | Other: Questionaire* Premenopausal women aged 18-55 years, at time of operation * Endometriosis confirmed with surgery and histologic staging (Report of the surgery available) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- From our database of operated endometriosis patients ranging from 2016-2020 100 women will be identified within the first phone call as cases with endometriosis and migraine and the threefold number (n=300) as control with endometriosis only.
Key inclusion criteria (3 listed)
- Premenopausal women aged 18-55 years, at time of operation
- Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
- For the cases migraine needs to be confirmed during the interview according to the IHS criteria.
Key exclusion criteria (1 listed)
- Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)
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 |
|---|---|---|
| Questionaireonly questionaire | Other | Endometriosis, Endometriosis & Migraine |
Primary outcome
Endometriosis stage
Time frame: 4 years
endometriosis stage confirmed by laparascopy compared to the control group
5 secondary outcomes
infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations
Time frame: 4 years
and age of first symptoms for both conditions and age at first operation
Time frame: 4 years
family history with first-degree relatives,
Time frame: 4 years
Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response,
Time frame: 4 years
response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted
Time frame: 4 years
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 24 Feb 2022.
- Derived from this study: PubMed 37132337Dietrich H, Knobel C, Portmann L, Metzler J, Muendane A, Niggli A, Neumeier MS, Imesch P, Merki-Feld GS. Endometriosis features and dienogest tolerability in women with depression: a case-control study. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):198-204. doi: 10.1080/13625187.2023.2199899. Epub 2023 May 3.
- Derived from this study: PubMed 36897310Neumeier MS, Pohl H, Dietrich H, Knobel C, Portmann L, Metzler J, Imesch P, Merki-Feld GS. Endometriosis Features in Women With and Without Migraine. J Womens Health (Larchmt). 2023 May;32(5):598-607. doi: 10.1089/jwh.2022.0359. Epub 2023 Mar 10.
- 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 Endometriosis and Migraine, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 1 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 24 Feb 2022. 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 Switzerland. 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?
Endometriosis stage (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816357, which also lists 2 linked publications.
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 24 Feb 2022.