MenopausePhase 1NCT01596010
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
A Phase 1 study testing 2 mg estradiol / 1 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 investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- 2 mg estradiol / 1 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
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Nov 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
- Non-smoking
- Body Mass Index (BMI) maximum 35.0 kg/m^2
- Able to understand, read and speak German fluently
- Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
- Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration
Who cannot join
- Known or suspected allergy to trial products or related products
- Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
- Known, suspected or history of breast cancer
- Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
- Abnormal genital bleeding of unknown aetiology
- Known insulin dependent as well as non-insulin dependent diabetes mellitus
- Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C
- Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
- Being tested
- 2 mg estradiol / 1 mg norethisterone acetate (NETA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg estradiol / 1 mg norethisterone acetate (NETA)Drug
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| New formulation | Experimental | Not described Receives: Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA) |
| Old formulation | Active comparator | Not described Receives: Drug: 2 mg estradiol / 1 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 (0-t)
Measured: Up to 72 hours after trial product administration
Cmax, maximum concentration
Measured: Up to 72 hours after trial product administration
Secondary outcomes (5)
Time to maximum (tmax)
Measured: Up to 72 hours after trial product administration
Area under the curve from time zero to infinity
Measured: Up to 72 hours after trial product administration
Terminal half-life (t½)
Measured: Up to 72 hours after trial product administration
Terminal rate constant
Measured: Up to 72 hours after trial product administration
Incidence of adverse events (AEs)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 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
- NCT01596010
- Sponsor's protocol ID
- KLI-1915
- Other IDs
- 2007-003350-28
- Status last verified
- Mar 2015
- First submitted
- 9 May 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone
- ClinicalTrials.gov ID
- NCT01596010
- Acronym / sponsor ID
- KLI-1915
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 10 May 2012 (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 investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New formulation | Experimental | Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA) |
| Old formulation | Active comparator | Drug: 2 mg estradiol / 1 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 (6 listed)
- Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
- Non-smoking
- Body Mass Index (BMI) maximum 35.0 kg/m^2
- Able to understand, read and speak German fluently
- Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
Key exclusion criteria (8 listed)
- Known or suspected allergy to trial products or related products
- Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
- Known, suspected or history of breast cancer
- Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
- Abnormal genital bleeding of unknown aetiology
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 |
|---|---|---|
| 2 mg estradiol / 1 mg norethisterone acetate (NETA)A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally. | Drug | New formulation, Old formulation |
Primary outcome
Area under the Curve (0-t)
Time frame: Up to 72 hours after trial product administration
Cmax, maximum concentration
Time frame: Up to 72 hours after trial product administration
5 secondary outcomes
Time to maximum (tmax)
Time frame: Up to 72 hours after trial product administration
Area under the curve from time zero to infinity
Time frame: Up to 72 hours after trial product administration
Terminal half-life (t½)
Time frame: Up to 72 hours after trial product administration
Terminal rate constant
Time frame: Up to 72 hours after trial product administration
Incidence of adverse events (AEs)
Time frame: Week 8
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 18 Mar 2015.
- 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 2 mg estradiol / 1 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 6 inclusion and 8 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 18 Mar 2015. 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 (0-t) (time frame: Up to 72 hours after trial product administration). 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 18 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.