This study has been transitioned to CTIS with ID 2024-517127-40-00 check the CTIS register for the current data. To study the effects of continuous use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared to vitamin E (400 IU/day) in the…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of monthly migraine days
Secondary outcome
- number of monthly headache days
- number of monthly migraine and probable migraine attacks
- 50% response rates for migraine days
- number of (severe) adverse events
Background summary
The incidence and prevalence of migraine is three times higher in women than in
men. Clinical and epidemiological studies suggest a prominent role for sex
hormones in female migraine patients. Menstruation is an important factor
increasing the susceptibility for an upcoming attack.1 Perimenstrual migraine
attacks are also more disabling, longer lasting, and more difficult to treat
than other attacks.2-5 Hormonal fluctuations during menopausal transition are
associated with increased susceptibility for migraine as well.6 Thus, sex
hormonal conditions are known to affect the susceptibility for migraine attacks
in women, but there is a lack of understanding the underlying
pathophysiological mechanism. Currently, there is no evidence-based hormonal
intervention for the treatment of migraine in women.
Study objective
This study has been transitioned to CTIS with ID 2024-517127-40-00 check the CTIS register for the current data.
To study the effects of continuous use of ethinylestradiol/levonorgestrel
(30/150 µg/day) compared to vitamin E (400 IU/day) in the treatment of
menstrually-related migraine and migraine during perimenopause.
Study design
Open-label randomized controlled trial
Intervention
Continuous ethinylestradiol/levonorgestrel 30/150 µg/day versus vitamin E 400
IU/day
Study burden and risks
The study will encompass a period of 4 months (1 baseline month and 3 treatment
months). Patients have to fill out daily headache diaries throughout the study
using a web-based app (5 minutes daily). Patients visit the headache clinic
thrice, once for inclusion, once during the baseline period and once after 3
months of therapy. During the first and last visit blood samples will be taken.
Patients will fill out one baseline questionnaire (1 hour), one expectations
questionnaire (5 minutes) and one follow-up questionnaire (15 minutes).
Patients will be contacted twice during follow-up to evaluate (S)AE*s.
Treatment with the oral contraceptive pill is accompanied by a very low risk of
developing thromboembolisms. In- and exclusion criteria are formulated to
decrease this risk (exclusion of smokers and migraine with aura). In addition,
a DSMB will be established.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- female
- menstrually-related migraine OR migraine in the early menopausal transition
phase
- age >= 18
- demonstrated at least 80% compliance with eDiary during baseline period
- no or stable for at least two months on prophylactic medication
Exclusion criteria
- Smoking
- Migraine with aura
- Chronic migraine with 15 or more headache days per month/with 8 or more
migraine days per month
- Medication-overuse headache (ICHD-3 criteria)
- Women who are breastfeeding, pregnant, or planning to become pregnant
- Oral contraceptive use and not willing to undergo washout period (stop for
two consecutive months)
- Vitamin E use at start of the study
- Use of other sex hormone containing treatments
- Increased risk of VTE: history of VTE or thrombophlebitis, hereditary
predisposition for VTE (APC resistance, protein C or S deficiency, antithrombin
deficiency), VTE in first-degree family member with young age, long term
immobilisation
- Increased risk of ATE: history of ATE, hereditary predisposition for ATE
(hyperhomocysteinemia, antiphospholipid antibodies), ATE in first-degree family
member with young age, diabetes mellitus, total cholesterol >= 6.5
- Other contraindication for oral contraceptives: liver malignancy,
schistosomiasis, HIV/aids, use of immunosuppressives, tuberculosis,
sex-hormone-dependent malignancies (breast, endometrial or ovary carcinomas),
pancreatitis, vaginal bleeding with unknown cause, other diseases that can
influence vessels (malignancies, heart valve disorders, atrial fibrillation,
SLE, haemolytic uremic syndrome, chronic inflammatory bowel disease, sickle
cell disease)
- Contraindication for vitamin E: vitamin K deficiency
- Hypersensitivity for any of the compounds in oral contraceptive or vitamin E
- Spontaneous postmenopausal status (menstrual bleedings have ceased for 12
consecutive months)
- Iatrogenic postmenopausal status
- Inability to complete the electronic diary in an accurate manner
- Any serious illness that can compromise study participation
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-517127-40-00 |
| EudraCT | EUCTR2018-004096-12-NL |
| CCMO | NL67994.058.19 |