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Feasibility Study Into the Contraceptive Effect of Estetrol

NCT00563472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-05-07

No results posted yet for this study

Summary

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).

Conditions

  • Healthy

Interventions

DRUG

estetrol

10 mg orally per day for 28 days

DRUG

estetrol

20 mg orally per day for 28 days

DRUG

estetrol and desogestrel

20 mg estetrol and 150 microg desogestrel orally per day for 28 days

DRUG

estetrol and progesterone

20 mg estetrol and 200 mg progesterone orally per day for 28 days

Sponsors & Collaborators

  • Pantarhei Bioscience

    lead INDUSTRY

Principal Investigators

  • H. Coelingh Bennink, MD, PhD · Pantarhei Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00563472 on ClinicalTrials.gov