HealthyPhase 1NCT00163033
Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women
A Phase 1 study testing estetrol in people with Healthy, run by Pantarhei Bioscience at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- estetrol
- How many people
- 49 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2005to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 6 months for depot preparations.
Show all 26Show fewer
- 8 weeks for oral preparations or progestogen containing intrauterine device (IUD).
- 4 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.
- Disturbance of liver function: cholestatic jaundice, a history of jaundice in pregnancy or jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome.
- Known or suspected estrogen-dependent tumors or endometrial hyperplasia
- Undiagnosed vaginal bleeding.
- Porphyria.
- A history during pregnancy or previous estrogen use of severe pruritus, herpes gestationis, or deterioration of otosclerosis.
- Any medication (including over-the-counter [OTC] products) from 14 days prior to the day of dosing except for occasional non-steroidal anti-inflammatory drugs (NSAID; e.g. ibuprofen); paracetamol is not permitted.
- Any enzyme affecting drugs from 30 days prior to Day 1 and the use of griseofulvin, primidone, oxcarbazepine, topiramate, felbamate, or herbal remedies containing hypericum perforatum (St. John's wort).
- Presence of significant allergies or other serious diseases.
- Smoking more than 10 cigarettes or equivalent per day.
- Administration of investigational drugs within 3 months before start of study medication.
- A history of (within 12 months) alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Kendle Clinical Pharmacology Unit
Utrecht, Utrecht, 3584 CJ
About this study
Official title: Phase I Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics of 3 Dosages of Estetrol, the Lowest Dose of 2 mg Estetrol Compared With 2 mg of E2, After Daily Oral Administration for 28 Days in Healthy Postmenopausal Women
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.
Read the detailed description
This is a partly randomized open-label study in healthy postmenopausal women. Groups are treated in the following sequence: first a 2 mg estetrol group together with a 2 mg estradiol group. When the dose of 2 mg estetrol is safe and the tolerability is good, a next higher dose group of estetrol will start, possibly followed by two next higher dose groups if the previous dose group is safe and the tolerability is good.
The primary objective of this study is to investigate the safety and tolerability of estetrol during multiple dosing for 28 days. Furthermore steady state pharmacokinetics and some pharmacodynamic parameters of estetrol will be investigated. In addition, the pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with those of the 2 mg estradiol group.
In each group 5 postmenopausal women will be included with > 50 hot flushes per week and 5 postmenopausal women with < 10 hot flushes per week. These criteria are set to get a more homologous composition in each group.
- Conditions
- Healthy
- Being tested
- estetrol
- Keywords
- phase I study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estetrolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pantarhei Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herjan Coelingh Bennink, MD, PhD, Study director, Pantarhei Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163033
- Sponsor's protocol ID
- PR3054
- Status last verified
- May 2012
- First submitted
- 12 Sep 2005
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics of 3 Dosages of Estetrol, the Lowest Dose of 2 mg Estetrol Compared With 2 mg of E2, After Daily Oral Administration for 28 Days in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00163033
- Acronym / sponsor ID
- PR3054
- Conditions
- Healthy
- Keywords
- phase I study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Pantarhei BioscienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a partly randomized open-label study in healthy postmenopausal women. Groups are treated in the following sequence: first a 2 mg estetrol group together with a 2 mg estradiol group. When the dose of 2 mg estetrol is safe and the tolerability is good, a next higher dose group of estetrol will start, possibly followed by two next higher dose groups if the previous dose group is safe and the tolerability is good.
The primary objective of this study is to investigate the safety and tolerability of estetrol during multiple dosing for 28 days. Furthermore steady state pharmacokinetics and some pharmacodynamic parameters of estetrol will be investigated. In addition, the pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with those of the 2 mg estradiol group.
In each group 5 postmenopausal women will be included with > 50 hot flushes per week and 5 postmenopausal women with < 10 hot flushes per week. These criteria are set to get a more homologous composition in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estetrol | Drug | – |
Primary outcome
safety of estetrol
tolerability of estetrol
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herjan Coelingh Bennink, MD, PhD study director
Pantarhei Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing estetrol in people with Healthy, run by Pantarhei Bioscience at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of estetrol. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012.