MenopausePhase 4NCT01705249
Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women
A Phase 4 study testing 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) in people with Menopause and Healthy, run by Novo Nordisk A/S at 19 sites in 2 countries.
Trial summary
This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)). Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 14 Aug 2001to 6 Jun 2003
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women
- At least 3 months on Trisekvens® before screening period
- Ability to understand and comply with the protocol requirements
Who cannot join
- Less than 12 months or more than 36 months postmenopausal judged by the Investigator
- Known, suspected, or past history of hormone dependent tumor/cancers
- Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions
- Ischemic heart disease or myocardial infarction within 6 months prior to randomization
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Sweden14 sites
Novo Nordisk Investigational Site
Borås, 503 32
Novo Nordisk Investigational Site
Gothenburg, 411 19
Novo Nordisk Investigational Site
Gothenburg, 418 33
Novo Nordisk Investigational Site
Kungsbacka, 434 30
Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Linköping, 582 20
Novo Nordisk Investigational Site
Linköping, 582 22
Novo Nordisk Investigational Site
Norrköping, 602 22
Novo Nordisk Investigational Site
Norrköping, 602 32
Novo Nordisk Investigational Site
Sigtuna, 193 30
Novo Nordisk Investigational Site
Södertälje, 151 23
Novo Nordisk Investigational Site
Stockholm, 111 37
Novo Nordisk Investigational Site
Stockholm, 111 57
Novo Nordisk Investigational Site
Uddevalla, 451 30
Norway5 sites
Novo Nordisk Investigational Site
Kristiansand
Novo Nordisk Investigational Site
Kristiansund
Novo Nordisk Investigational Site
Larvik
Novo Nordisk Investigational Site
Oslo, 0309
Novo Nordisk Investigational Site
Trondheim, NO-7012
About this study
Official title: Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®
This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).
- Being tested
- 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.
1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)Drug
After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.
| Study group | Role | What they receive |
|---|---|---|
| estradiol / norethisterone acetate | Experimental | 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.
Postmenopausal women's acceptance of bleeding
Measured: After 24 weeks of treatment
Secondary outcomes (2)
Bleeding profile in postmenopausal women
Measured: After 24 weeks of treatment
Acceptance of hot flushes and breast tenderness
Measured: After 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study start14 Aug 2001
- Primary completion6 Jun 2003
- Study completion6 Jun 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 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
- NCT01705249
- Sponsor's protocol ID
- KLIM-1408
- Status last verified
- Feb 2017
- First submitted
- 8 Oct 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®
- ClinicalTrials.gov ID
- NCT01705249
- Acronym / sponsor ID
- KLIM-1408
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2001 (actual)
- Primary completion
- 6 Jun 2003 (actual)
- Study completion
- 6 Jun 2003 (actual)
- First posted
- 12 Oct 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 study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| estradiol / norethisterone acetate | Experimental | Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy women
- At least 3 months on Trisekvens® before screening period
- Ability to understand and comply with the protocol requirements
Key exclusion criteria (4 listed)
- Less than 12 months or more than 36 months postmenopausal judged by the Investigator
- Known, suspected, or past history of hormone dependent tumor/cancers
- Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions
- Ischemic heart disease or myocardial infarction within 6 months prior to randomization
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 |
|---|---|---|
| 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®. | Drug | estradiol / norethisterone acetate |
Primary outcome
Postmenopausal women's acceptance of bleeding
Time frame: After 24 weeks of treatment
2 secondary outcomes
Bleeding profile in postmenopausal women
Time frame: After 24 weeks of treatment
Acceptance of hot flushes and breast tenderness
Time frame: After 24 weeks of treatment
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 28 Feb 2017.
- 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
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) in people with Menopause and Healthy, run by Novo Nordisk A/S at 19 sites in 2 countries.
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 3 inclusion and 4 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Sweden, Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postmenopausal women's acceptance of bleeding (time frame: After 24 weeks of treatment). 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 28 Feb 2017.