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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
449
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Ashfield, New South Wales, Australia
Unnamed facility
Blacktown, New South Wales, Australia
Unnamed facility
Caringbah, New South Wales, Australia
Unnamed facility
Sydney, New South Wales, Australia
Unnamed facility
Fortitude Valley, Queensland, Australia
Unnamed facility
Kipparing, Queensland, Australia
Unnamed facility
Adelaide, South Australia, Australia
Unnamed facility
Norwood, South Australia, Australia
Unnamed facility
Clayton, Victoria, Australia
Unnamed facility
Nedlands, Western Australia, Australia
...and 53 more locations
Time frame: Throughout
General physical and gynecological examination
Time frame: Screening and Final Visit