| Condition or disease | Intervention/treatment |
|---|---|
| Migraine | Behavioral: Diary |
Participant recruitment is performed through advertisement placed in University Zürich (USZ) online. Advertisement in offices of neurologists and headache specialists, homepage of the Swiss headache society.
Interested women contact the investigators via email and are called back by one of the study doctors or students within 1 day from Monday-Friday. This phone call is thought to inform the women about the study in more detail and for the investigators to check eligibility. During this call the participants are informed about the study procedure and can ask any question. Here most important points are use of a CHC in a 21/7 regimen, regular (at least once on two months) withdrawal migraine/headaches, intention to continue the use of the contraceptive for 3 more months.
If the participants decide to participate, inclusion and exclusion criteria are checked. If women are applicable they receive the consent form and the study information with an envelope for return. If more questions come up the investigators are available per email and phone for answers. If a patient doesn't return the consent form the investigator will delete the personal data, which collected before. Only the year of birth will be noted in the personal data.
After consent participants receive headaches diaries (with mail /post) and a prepaid envelope (for return). Participants are also offered the option to return their diaries electronically via email to the study doctor. Furthermore participants receive in a second phone contact instructions, how to fill in the headache diary and the day of study start (first day of the next pill package).
Headache diaries should be returned monthly (per email or post) and are conducted for 3 pill cycles.
If complete headache diaries are not returned participants will be contacted per email after 1 week to remind the participants. If this email is not being answered within another week a phone contact will take place to identify potential reasons for noncompliance or withdrawal of consent or drop out.
Observation period 3 pill cycles : 3 times 28 days
Outcomes of the Research Project:
Statistical Methodology:
| Study Type : | Observational |
| Actual Enrollment : | 47 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives |
| Actual Study Start Date : | January 2017 |
| Actual Primary Completion Date : | April 15, 2019 |
| Actual Study Completion Date : | August 31, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
premenopausal women
diary
|
Behavioral: Diary |
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Switzerland | |
| Universitätsspital Zürich | |
| Zürich, Switzerland | |
| Study Director: | Gabriele Merki, Professor | University Hospital, Zürich |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | September 27, 2017 | ||||
| First Posted Date | July 9, 2019 | ||||
| Last Update Posted Date | April 30, 2021 | ||||
| Actual Study Start Date | January 2017 | ||||
| Actual Primary Completion Date | April 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Migraine in the pill-free interval [ Time Frame: up to 3 months ] Migraine at each day of the pill-free interval
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Diary-based Study on the Course of Hormone-withdrawal Migraines | ||||
| Official Title | Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives | ||||
| Brief Summary | Single centered diary-based study to identify course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives Objectives of the Research Project: to identify the course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives (CHC) | ||||
| Detailed Description |
Participant recruitment is performed through advertisement placed in University Zürich (USZ) online. Advertisement in offices of neurologists and headache specialists, homepage of the Swiss headache society. Interested women contact the investigators via email and are called back by one of the study doctors or students within 1 day from Monday-Friday. This phone call is thought to inform the women about the study in more detail and for the investigators to check eligibility. During this call the participants are informed about the study procedure and can ask any question. Here most important points are use of a CHC in a 21/7 regimen, regular (at least once on two months) withdrawal migraine/headaches, intention to continue the use of the contraceptive for 3 more months. If the participants decide to participate, inclusion and exclusion criteria are checked. If women are applicable they receive the consent form and the study information with an envelope for return. If more questions come up the investigators are available per email and phone for answers. If a patient doesn't return the consent form the investigator will delete the personal data, which collected before. Only the year of birth will be noted in the personal data. After consent participants receive headaches diaries (with mail /post) and a prepaid envelope (for return). Participants are also offered the option to return their diaries electronically via email to the study doctor. Furthermore participants receive in a second phone contact instructions, how to fill in the headache diary and the day of study start (first day of the next pill package). Headache diaries should be returned monthly (per email or post) and are conducted for 3 pill cycles. If complete headache diaries are not returned participants will be contacted per email after 1 week to remind the participants. If this email is not being answered within another week a phone contact will take place to identify potential reasons for noncompliance or withdrawal of consent or drop out. Observation period 3 pill cycles : 3 times 28 days Outcomes of the Research Project:
Statistical Methodology:
|
||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Premenopausal women | ||||
| Condition | Migraine | ||||
| Intervention | Behavioral: Diary | ||||
| Study Groups/Cohorts | premenopausal women
diary
Intervention: Behavioral: Diary
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
47 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | August 31, 2019 | ||||
| Actual Primary Completion Date | April 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04012593 | ||||
| Other Study ID Numbers | 2016-01791 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | University of Zurich | ||||
| Study Sponsor | University of Zurich | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | University of Zurich | ||||
| Verification Date | July 2019 | ||||