Healthy Clinical Trial
Official title:
A Feasibility Study Into the Contraceptive Effect of Estetrol Alone or Combined With Either Progesterone or Desogestrel by Daily Oral Administration to Healthy Female Volunteers for 28 Days.
This is an open study in 50 young, healthy, female volunteers. Women who want to participate
and who are using hormonal contraception stop using their hormonal contraceptive and wait
for their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use
hormonal contraception wait for their next menstruation. From the 9th day after start of the
menstruation onwards follicle growth will be monitored by ultrasonography until ovulation
occurs or until day 24 after start of their menses. Women who ovulate within 24 days after
start of their menses will be eligible to participate and will be stratified in one of 4
groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg
desogestrel and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for
28 days. Treatment will start on the first day of their menses after the pre-treatment
cycle.
During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO)
axis will be investigated by measuring follicular development using ultrasonography and by
determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone
(LH), estradiol (E2) and Progesterone (P).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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