MenopausePhase 1NCT01477632
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
A Phase 1 study testing 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) and 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) in people with Menopause and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) and 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Jun 2005
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Postmenopausal
- Caucasian race
- Smoking (up to 5 cig./per day) is allowed
- Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination
Who cannot join
- Known or suspected allergy to trial products or related products
- Previous participation in this trial
- Previous estrogen and/or progestin hormone replacement therapy
- Known, suspected or history of breast cancer
- Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
- Body Mass Index (BMI) above 35.0 kg/m^2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate
This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.
- Being tested
- 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA), 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)Drug
A single oral dose of 2 tablets under fasting conditions
0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)Drug
A single oral dose of 2 tablets under fasting conditions
1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)Drug
A single oral dose of 1 tablet under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) |
| B | Experimental | Not described Receives: Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) |
| C | Active comparator | Not described Receives: Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC(0-∞))
Maximal concentration (Cmax)
Time to maximum (tmax)
Secondary outcomes (2)
Area Under the Curve (AUC) from dosing up to last sample
Terminal half-life (t½)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMar 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477632
- Sponsor's protocol ID
- ALD-1640
- Other IDs
- 2004-002457-32, 2004
- Status last verified
- Jan 2016
- First submitted
- 18 Nov 2011
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate
- ClinicalTrials.gov ID
- NCT01477632
- Acronym / sponsor ID
- ALD-1640
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 22 Nov 2011 (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.
This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) |
| B | Experimental | Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) |
| C | Active comparator | Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Postmenopausal
- Caucasian race
- Smoking (up to 5 cig./per day) is allowed
- Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination
Key exclusion criteria (6 listed)
- Known or suspected allergy to trial products or related products
- Previous participation in this trial
- Previous estrogen and/or progestin hormone replacement therapy
- Known, suspected or history of breast cancer
- Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
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 |
|---|---|---|
| 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)A single oral dose of 2 tablets under fasting conditions | Drug | A |
| 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)A single oral dose of 2 tablets under fasting conditions | Drug | B |
| 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)A single oral dose of 1 tablet under fasting conditions | Drug | C |
Primary outcome
Area under the curve (AUC(0-∞))
Maximal concentration (Cmax)
Time to maximum (tmax)
2 secondary outcomes
Area Under the Curve (AUC) from dosing up to last sample
Terminal half-life (t½)
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 15 Jan 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) and 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) in people with Menopause and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
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 6 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 15 Jan 2016. 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 Germany. 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?
Area under the curve (AUC(0-∞)). The study lists 3 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 15 Jan 2016.