Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women

NCT00163033 | Completed Phase 1

• 1 other identifier: PR3054
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Estetrol is a natural compound that is produced by the fetus during fetal life and circulates in the unborn child and the mother. It is an estrogenic compound. In this study the safety and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.

Conditions

Healthy

Keywords

phase I study

Outcome Measures

Primary Outcomes (2)

• safety of estetrol

• tolerability of estetrol

Secondary Outcomes (4)

• steady state pharmacokinetics of estetrol

• pharmacodynamic effects of estetrol

• to compare the pharmacokinetics and pharmacodynamic effects of 2 mg estetrol with 2 mg estradiol

• to investigate the effect on the number of hot flushes and sweating of 2 mg estetrol compared with 2 mg estradiol

Interventions

estetrol DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women not older than 70 years of age at the time of screening (menopause defined as ≥ 6 months amenorrhea with serum follicle-stimulating hormone \[FSH\] levels ≥ 40 IU/L and serum E2 \< 73 pmol/L).
• Body mass index 18-30 kg/m2 inclusive.
• Good physical and mental health, as judged by the Investigator, determined by medical history, physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) recording.
• Willing to give written informed consent.
• Either \> 50 hot flushes per week or \< 10 hot flushes per week

You may not qualify if:

• Clinically significant abnormal results of routine hematology, serum biochemistry, urinalysis, and/or ECG in the opinion of the Investigator at screening.
• Clinically significant abnormal mammogram (presence of any non-cystic mass) within one year before study start.
• Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology or an endometrium greater than 6 mm).
• A cervical smear with clinically relevant abnormal cytology within one year before study start.
• Previous use of estrogen/progestogen within:
• months for depot preparations.
• weeks for oral preparations or progestogen containing intrauterine device (IUD).
• weeks for transdermal preparations.
• Use of hormone containing implant at any time.
• Contraindications for using steroids:
• A history of, or existing thromboembolic, cardiovascular, or cerebrovascular disorder.
• A history of, or existing conditions predisposing to, or being prodrome of, a thrombosis.
• A known defect in the blood coagulation system (e.g. deficiencies in antithrombin-III \[AT-III\], protein C, S, and activated protein C \[APC\] resistance).
• A medical history positive for the presence of more than one risk factor for vascular disease (e.g. dyslipoproteinemia; diabetes mellitus; hyperhomocysteinemia; systemic lupus erythematosus; chronic inflammatory bowel disease; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 30-35).
• Hypertension, i.e. systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg.

Sponsors & Collaborators

• Pantarhei Bioscience: lead

Study Sites (1)

Kendle Clinical Pharmacology Unit

Utrecht, Utrecht, 3584 CJ, Netherlands

Location

MeSH Terms

Interventions

Estetrol

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

Study Officials

• Herjan Coelingh Bennink, MD, PhD

  Pantarhei Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 13, 2005
• Study Start: June 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

NL (1)