Headache, Oral Contraceptive, Pelvic Pain
Conditions
Keywords
Combined Oral Contraceptives, Pelvic Pain, Headache
Brief summary
The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).
Interventions
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval
DRUGEncapsulated Microgynon + Placebo
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive) * Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of \>/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28. * Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening) * Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
Exclusion criteria
* Women with any contraindication for oral contraceptive use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint | Baseline to cycle 6 |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28 | Baseline to cycle 6 |
| Prevalence of individual hormone-related symptoms during cycle days 1 to 21 | Baseline to cycle 6 |
| Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator | Baseline, cycle 3 and cycle 6 |
| Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3 | Baseline to cycle 3 |
| Rescue medication consumption | Baseline to cycle 6 |
| QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI) | Baseline, cycle 2 and cycle 5 |
| AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight | Throughout |
| General physical and gynecological examination | Screening and Final Visit |
| Bleeding pattern and cycle control | Throughout |
Countries
Australia, Finland, France, Germany, Mexico, Spain, Switzerland, Thailand, United Kingdom
Outcome results
None listed