A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles
20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles
Dinox BV
Groningen, Netherlands
Proportion of subjects with ovarian inhibition at treatment Cycle 1
Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on: * the follicular size assessed by transvaginal ultrasound (TVUS) * endogenous hormone levels: serum E2, and serum progesterone.
Time frame: All assessments will be performed once every 3 days starting treatment Cycle 1 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).
Proportion of subjects with ovarian inhibition at treatment Cycle 3
Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on: * the follicular size assessed by TVUS * endogenous hormone levels: serum E2, and serum progesterone.
Time frame: All assessments will be performed once every 3 days starting treatment Cycle 3 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).
Serum level of luteinizing hormone (LH)
Blood samples will be taken at regular time points defined in the time frame.
Time frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)
Serum level of follicle stimulating hormone (FSH)
Blood samples will be taken at regular time points defined in the time frame.
Time frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)
Serum level of estradiol (E2)
Blood samples will be taken at regular time points defined in the time frame.
Time frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)
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Serum level of progesterone (P)
Blood samples will be taken at regular time points defined in the time frame.
Time frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days)
Maximum endometrial thickness
Endometrial thickness will be measured using transvaginal ultrasound (TVUS). Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.
Time frame: From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)
Mean diameter of the largest follicle
Follicular size will be measured using TVUS.
Time frame: Day 3 to Day 24 of Post-Treatment Cycle
Number of participants who experience at least one Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 to Follow-Up Visit (+ 30 days)
Number of participants who experience pregnancy during treatment
Time frame: Cycle 1 Day 1 to Follow-Up Visit (+ 30 days) (each treatment cycle = 28 days)
Number of participants who experience a clinically significant change in physical examination results
Time frame: Day 1 to End of Follow-Up Visit (+ 30 Days)
Number of participants who experience a clinically significant change in gynecological examination results
Time frame: Day 1 to End of Follow-Up Visit (+ 30 Days)
Number of participants who experience a clinically significant change in clinical laboratory results
Time frame: Day 1 to End of Follow-Up Visit (+ 30 Days)
Number of participants who experience a clinically significant change in electrocardiogram (ECG) results
Time frame: Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days)
Number of participants who experience a clinically significant change in echocardiogram results
Time frame: Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days)
Change from Baseline in diastolic blood pressure
Time frame: From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)
Change from Baseline in systolic blood pressure
Time frame: From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)
Change from Baseline in pulse rate
Time frame: From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days)