This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
592
4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days
4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days
Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).
Time frame: Cycle days 22 - 28 of baseline cycle and cycle 4.
change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score),
Time frame: Cycle days 22 - 28 of baseline cycle and cycle 4
change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1),
Time frame: Cycle days 22 - 28 of baseline cycle and cycle 4
change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,
Time frame: Cycle days 22 - 28 of baseline cycle and cycle 4
rescue medication consumption
Time frame: baseline cycle and cycle 4
bleeding pattern
Time frame: reference period is 90 days.
evaluation of questionnaires: Q-LES-Q (short version)
Time frame: baseline cycle and cycle 4
Adverse Event collection
Time frame: up to 10 days after end of cycle 4
heart rate
Time frame: up to 10 days after end of cycle 4
blood pressure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Rosario, Santa Fe Province, Argentina
Unnamed facility
Santiago, Santiago Metropolitan, Chile
Unnamed facility
Santiago, Santiago Metropolitan, Chile
Unnamed facility
Santiago, Chile
Unnamed facility
Santiago, Chile
Unnamed facility
Temuco, Chile
Unnamed facility
Bucaramanga, Santander Department, Colombia
Unnamed facility
Bogotá, Colombia
Unnamed facility
Medellín, Colombia
...and 34 more locations
Time frame: up to 10 days after end of cycle 4