A Phase 3 interventional study of EV/DNG (Qlaira, BAY86-5027) and Encapsulated Microgynon + Placebo in Oral Contraceptive, Headache and Pelvic Pain, sponsored by Bayer. Completed at 63 sites in 9 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by Bayer · Phase 3, Interventional, and Prevention
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).
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 449 is above the median of 60 across 918 interventional studies indexed under Headache.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Drug: EV/DNG (Qlaira, BAY86-5027)
Drug: Encapsulated Microgynon + Placebo
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
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
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
Time frame: Baseline to cycle 6
Rescue medication consumption
Time frame: Baseline to cycle 6
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Time frame: Baseline to cycle 6
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
Time frame: 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
Time frame: 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
Time frame: Baseline to cycle 3
Bleeding pattern and cycle control
Time frame: Throughout
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
Time frame: Baseline, cycle 2 and cycle 5
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
Time frame: Throughout
General physical and gynecological examination
Time frame: Screening and Final Visit
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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