MenopausePhase 3CHOICENCT00184795

Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations

A Phase 3 study testing 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) and 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) in people with Menopause and Menopausal Vasomotor Symptoms, run by Novo Nordisk A/S at 91 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will… Read more about this study

Who is it for?: Ages 45 to 65 years, women only
Conditions the study is for: Menopause, Menopausal Vasomotor Symptoms
What is being tested?: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) and 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 576 participants
Where: 91 sitesin 10 countries
Study dates: 28 May 2004to 4 May 2005
Phase: Phase 3
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 45 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal status
Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
Subject with an intact uterus

Who cannot join

In accordance with existing labelling for estrogen/progestogen combinations
Body Mass Index (BMI) > 35.0 kg/m2
Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin

Trial locations and contacts

91 sites in 10 countries.

Country

City, postcode or hospital

91 sites in 10 countries

United Kingdom24 sites

Novo Nordisk Investigational Site
Aldershot, GU12 5BA
Novo Nordisk Investigational Site
Bexhill-on-Sea, TN39 4SP
Novo Nordisk Investigational Site
Birmingham, BE9'1 2JL
Novo Nordisk Investigational Site
Bolton, BL1 6AF
Novo Nordisk Investigational Site
Chesterfield, Derbyshire, S40 4AA
Novo Nordisk Investigational Site
Chippenham, SN15 1HP
Novo Nordisk Investigational Site
Cornwell, TR1 2LZ
Novo Nordisk Investigational Site
Coventry, CV6 2FL
Novo Nordisk Investigational Site
Devon, BH15 2JB
Novo Nordisk Investigational Site
Hastings, TN34 3EY
Novo Nordisk Investigational Site
Hull, HU2 8PX
Novo Nordisk Investigational Site
Linclolshire, PE21 6PF
Novo Nordisk Investigational Site
Liverpool, L8 7SS
Novo Nordisk Investigational Site
London, SE1 9RT
Novo Nordisk Investigational Site
London, SE5 8RS
Novo Nordisk Investigational Site
London, W12 0HS
Novo Nordisk Investigational Site
Manchester, M13 0JH
Novo Nordisk Investigational Site
Norfolk, NR4 7UZ
Novo Nordisk Investigational Site
Oxford, OX3 9UD
Novo Nordisk Investigational Site
Reading, RG7 3SQ
Novo Nordisk Investigational Site
Sheffield, S1 2PJ
Novo Nordisk Investigational Site
Stoke-on-Trent, ST4 6QG
Novo Nordisk Investigational Site
Suffolk, IP33 1HE
Novo Nordisk Investigational Site
Watford, HA1 3UJ

Other trials in United Kingdom

France11 sites

Novo Nordisk Investigational Site
Amiens
Novo Nordisk Investigational Site
La Roche-sur-Yon, 85295
Novo Nordisk Investigational Site
Marseille, 13004
Novo Nordisk Investigational Site
Marseille, 13385
Novo Nordisk Investigational Site
Montpellier, 34000
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nice, 06000
Novo Nordisk Investigational Site
Nîmes, 30000
Novo Nordisk Investigational Site
Toulouse, 31059

Other trials in France

Germany10 sites

Novo Nordisk Investigational Site
Jessen, 06917
Novo Nordisk Investigational Site
Karlsruhe, 76199
Novo Nordisk Investigational Site
Leipzig, 04207
Novo Nordisk Investigational Site
Lorsch, 64653
Novo Nordisk Investigational Site
Rheine, 48431
Novo Nordisk Investigational Site
Rheinstetten, 76287
Novo Nordisk Investigational Site
Schorndorf, 73614
Novo Nordisk Investigational Site
Stuttgart, 70563
Novo Nordisk Investigational Site
Tübingen, 72076
Novo Nordisk Investigational Site
Völklingen, 66333

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Belgium9 sites

Novo Nordisk Investigational Site
Brussels, 1000
Novo Nordisk Investigational Site
Brussels, 1180
Novo Nordisk Investigational Site
Brussels, 1200
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Huy, 4500
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Liège, 4000
Novo Nordisk Investigational Site
Montigny-le-Tilleul, 6110
Novo Nordisk Investigational Site
Watermael-Boifort, 1170

Other trials in Belgium

Norway9 sites

Novo Nordisk Investigational Site
Grålum, 1713
Novo Nordisk Investigational Site
Hamar, NO-2317
Novo Nordisk Investigational Site
Kolbotn, 1410
Novo Nordisk Investigational Site
Lillestrøm, 2000
Novo Nordisk Investigational Site
Oslo, 0309
Novo Nordisk Investigational Site
Paradis, 5231
Novo Nordisk Investigational Site
Stavanger, 4088
Novo Nordisk Investigational Site
Stavanger, NO-4011
Novo Nordisk Investigational Site
Trondheim, NO-7012

Other trials in Norway

Denmark8 sites

Novo Nordisk Investigational Site
Allerød Municipality, 3450
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Frederiksberg, 2000
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
København N, 2400
Novo Nordisk Investigational Site
Næstved, 4700
Novo Nordisk Investigational Site
Odense C, 5000
Novo Nordisk Investigational Site
Virum, 2830

Other trials in Denmark

Sweden8 sites

Novo Nordisk Investigational Site
Gothenburg, 411 19
Novo Nordisk Investigational Site
Gothenburg, 416 85
Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Linköping, 582 22
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Malmö, 217 44
Novo Nordisk Investigational Site
Norrköping, 602 32
Novo Nordisk Investigational Site
Uppsala, 751 85

Other trials in Sweden

Finland5 sites

Novo Nordisk Investigational Site
Espoo, 02200
Novo Nordisk Investigational Site
Helsinki, 00100
Novo Nordisk Investigational Site
Oulu, 90100
Novo Nordisk Investigational Site
Tampere, 33101
Novo Nordisk Investigational Site
Turku, 20100

Other trials in Finland

Switzerland5 sites

Novo Nordisk Investigational Site
Bulle, 1630
Novo Nordisk Investigational Site
Frauenfeld, 8500
Novo Nordisk Investigational Site
Weinfelden, 8570
Novo Nordisk Investigational Site
Zurich, 8032
Novo Nordisk Investigational Site
Zurich, 8091

Other trials in Switzerland

Austria2 sites

Novo Nordisk Investigational Site
Vienna, A 1060
Novo Nordisk Investigational Site
Vienna, A 1090

Other trials in Austria

About this study

Official title: A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

Conditions: Menopause, Menopausal Vasomotor Symptoms
Being tested: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA), placebo
Keywords: Hot flashes
Medical subject headings: Hot Flashes

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
One tablet per day for 24 weeks
0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)Drug
One tablet per day for 24 weeks
placeboDrug
Placebo tablets for 24 weeks

Study groups in NCT00184795
Study group	Role	What they receive
ALD 0.1	Experimental	Not described Receives: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
ALD 0.25	Experimental	Not described Receives: Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in mean number of moderate to severe hot flushes per week
Measured: At week 8

Secondary outcomes (6)

Urogenital symptoms
Measured: Week 0; week 24
Vaginal cytology and pH
Measured: Week 0; week 24
Bleeding profile
Measured: Week 0; week 24
Adverse Events
Measured: Week 0; week 24
Menopausal symptoms and quality of life (Greene Climacteric Scale)
Measured: Week 0; week 24
Hot flush weekly weighted score
Measured: Week 0; week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 20044 May 2005

First posted16 Sep 2005 (estimated)
Study start28 May 2004
Primary completion4 May 2005
Study completion4 May 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 576 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00184795
Sponsor's protocol ID: ALD-1537
Other IDs: 2004-000103-17, 2004
Acronym: CHOICE
Status last verified: Feb 2017
First submitted: 13 Sep 2005
Last updated: 23 Feb 2017
Results posted: No
Data monitoring committee: No

Publications

Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.
PubMed 18202966
Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805.
PubMed 17487652
Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. doi: 10.1080/13697130701298107.
PubMed 17453860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms
ClinicalTrials.gov ID: NCT00184795
Acronym / sponsor ID: CHOICE / ALD-1537
Conditions: Menopause, Menopausal Vasomotor Symptoms
Keywords: Hot flashes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 576 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 28 May 2004 (actual)
Primary completion: 4 May 2005 (actual)
Study completion: 4 May 2005 (actual)
First posted: 16 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
ALD 0.1	Experimental	Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
ALD 0.25	Experimental	Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 45 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Postmenopausal status
Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
Subject with an intact uterus

Key exclusion criteria (4 listed)

In accordance with existing labelling for estrogen/progestogen combinations
Body Mass Index (BMI) > 35.0 kg/m2
Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin

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)One tablet per day for 24 weeks	Drug	ALD 0.1
0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)One tablet per day for 24 weeks	Drug	ALD 0.25
placeboPlacebo tablets for 24 weeks	Drug	Placebo

Primary outcome

Change in mean number of moderate to severe hot flushes per week
Time frame: At week 8

6 secondary outcomes

Urogenital symptoms
Time frame: Week 0; week 24
Vaginal cytology and pH
Time frame: Week 0; week 24
Bleeding profile
Time frame: Week 0; week 24
Adverse Events
Time frame: Week 0; week 24
Menopausal symptoms and quality of life (Greene Climacteric Scale)
Time frame: Week 0; week 24
Hot flush weekly weighted score
Time frame: Week 0; week 24

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 23 Feb 2017.
Results publication: PubMed 18202966Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.
Results publication: PubMed 17487652Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805.
Results publication: PubMed 17453860Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. doi: 10.1080/13697130701298107.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
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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

91 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 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 91 sites in United Kingdom, France, Germany, Belgium, Norway and 5 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in mean number of moderate to severe hot flushes per week (time frame: At week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00184795, which also lists 3 linked publications.

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 23 Feb 2017.