Feasibility Study Into the Contraceptive Effect of Estetrol

NCT00563472 | Completed Phase 2

• 1 other identifier: PR3081
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy female volunteers will participate in this study

Outcome Measures

Primary Outcomes (1)

• ovulation inhibition

  during treatment

Secondary Outcomes (1)

• endocrine parameters

  during treatment

Study Arms (4)

1

ACTIVE COMPARATOR

10 mg estetrol

Drug: estetrol

2

ACTIVE COMPARATOR

20 mg estetrol

Drug: estetrol

3

ACTIVE COMPARATOR

20 mg estetrol and 150 microg desogestrel

Drug: estetrol and desogestrel

4

ACTIVE COMPARATOR

20 mg E4 and 200 mg progesterone

Drug: estetrol and progesterone

Interventions

estetrol DRUG

10 mg orally per day for 28 days

1

estetrol and desogestrel DRUG

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

3

estetrol and progesterone DRUG

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

4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years and not older than 40 years of age
• Willing to use a barrier method of contraception during the wash-out cycle, the pre-treatment cycle, the period of study drug administration, the period of lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up visit if this 14-days period ends before the follow-up visit.
• Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of their menses, who have a subsequent P concentration of \> 16 nmol/l and whose next menstruation does not start within 6 days after ovulation
• Body Mass Index \> 18 and \<30 kg/m2
• Good physical and mental health
• Both ovaries visible upon ultrasonography
• Willing to give informed consent in writing

You may not qualify if:

• Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, and/or ECG in the opinion of the Investigator at screening.
• Known or suspected pregnancy
• Lactation
• Pregnancy during accurate hormonal contraceptive use
• Known or suspected breast cancer or a history of breast cancer
• Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology).
• A cervical smear with clinically relevant abnormal cytology within one year before study start.
• Previous use of depot progestogen preparations in the last 6 months.
• Contraindications for contraceptive steroids:
• a history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
• a history of, or existing conditions predisposing to, or being prodromi of, a thrombosis
• a known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance)
• heterozygous for a mutation in coagulation factor II and/or positive for factor V Leiden
• the presence of a severe or more than one risk factor for vascular disease (e.g. dyslipoproteinaemia; diabetes mellitus; hyperhomocysteinaemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 35; within 2 weeks after full remobilisation following surgery)
• hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg

Sponsors & Collaborators

• Pantarhei Bioscience: lead

Study Sites (1)

Dinox

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Interventions

Estetrol; Desogestrel; Progesterone

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes; Norpregnanes; Norsteroids; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• H. Coelingh Bennink, MD, PhD

  Pantarhei Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

NL (1)