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

February 22, 2017 updated by: Novo Nordisk A/S

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

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 be evaluated and compared to placebo over the six month treatment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

576

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, A 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1060
        • Novo Nordisk Investigational Site
  • Belgium
      • Brussels, Belgium, 1200
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1000
        • Novo Nordisk Investigational Site
      • Bruxelles, Belgium, 1180
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Huy, Belgium, 4500
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
      • Liège, Belgium, 4000
        • Novo Nordisk Investigational Site
      • Montigny-Le-Tilleul, Belgium, 6110
        • Novo Nordisk Investigational Site
      • Watermael-Boifort, Belgium, 1170
        • Novo Nordisk Investigational Site
  • Denmark
      • Allerød, Denmark, 3450
        • Novo Nordisk Investigational Site
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • København N, Denmark, 2400
        • Novo Nordisk Investigational Site
      • Næstved, Denmark, 4700
        • Novo Nordisk Investigational Site
      • Odense C, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Virum, Denmark, 2830
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, 02200
        • Novo Nordisk Investigational Site
      • Helsinki, Finland, 00100
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90100
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33101
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20100
        • Novo Nordisk Investigational Site
  • France
      • Amiens, France
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9, France, 85295
        • Novo Nordisk Investigational Site
      • MARSEILLE cedex 05, France, 13385
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 05, France, 34295
        • Novo Nordisk Investigational Site
      • Marseille, France, 13004
        • Novo Nordisk Investigational Site
      • Montpellier, France, 34000
        • Novo Nordisk Investigational Site
      • NANTES cedex 1, France, 44093
        • Novo Nordisk Investigational Site
      • NIMES cedex 9, France, 30000
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Nice, France, 06000
        • Novo Nordisk Investigational Site
      • Nimes, France, 30000
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex 9, France, 31059
        • Novo Nordisk Investigational Site
  • Germany
      • Jessen, Germany, 06917
        • Novo Nordisk Investigational Site
      • Karlsruhe, Germany, 76199
        • Novo Nordisk Investigational Site
      • Leipzig, Germany, 04207
        • Novo Nordisk Investigational Site
      • Lorsch, Germany, 64653
        • Novo Nordisk Investigational Site
      • Rheine, Germany, 48431
        • Novo Nordisk Investigational Site
      • Rheinstetten, Germany, 76287
        • Novo Nordisk Investigational Site
      • Schorndorf, Germany, 73614
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70563
        • Novo Nordisk Investigational Site
      • Tübingen, Germany, 72076
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
  • Norway
      • Grålum, Norway, 1713
        • Novo Nordisk Investigational Site
      • Hamar, Norway, NO-2317
        • Novo Nordisk Investigational Site
      • Kolbotn, Norway, 1410
        • Novo Nordisk Investigational Site
      • Lillestrøm, Norway, 2000
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0309
        • Novo Nordisk Investigational Site
      • Paradis, Norway, 5231
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, NO-4011
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4088
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7012
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 416 85
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 411 19
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 582 22
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 217 44
        • Novo Nordisk Investigational Site
      • Norrköping, Sweden, 602 32
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk Investigational Site
  • Switzerland
      • Bulle, Switzerland, 1630
        • Novo Nordisk Investigational Site
      • Frauenfeld, Switzerland, 8500
        • Novo Nordisk Investigational Site
      • Weinfelden, Switzerland, 8570
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8032
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aldershot, United Kingdom, GU12 5BA
        • Novo Nordisk Investigational Site
      • Bexhill-on-Sea, United Kingdom, TN39 4SP
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, BE9'1 2JL
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL1 6AF
        • Novo Nordisk Investigational Site
      • Chesterfield, Derbyshire, United Kingdom, S40 4AA
        • Novo Nordisk Investigational Site
      • Chippenham, United Kingdom, SN15 1HP
        • Novo Nordisk Investigational Site
      • Cornwell, United Kingdom, TR1 2LZ
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV6 2FL
        • Novo Nordisk Investigational Site
      • Devon, United Kingdom, BH15 2JB
        • Novo Nordisk Investigational Site
      • Hastings, United Kingdom, TN34 3EY
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU2 8PX
        • Novo Nordisk Investigational Site
      • Linclolshire, United Kingdom, PE21 6PF
        • Novo Nordisk Investigational Site
      • Liverpool, United Kingdom, L8 7SS
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 9RT
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W12 0HS
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE5 8RS
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 0JH
        • Novo Nordisk Investigational Site
      • Norfolk, United Kingdom, NR4 7UZ
        • Novo Nordisk Investigational Site
      • Oxford, United Kingdom, OX3 9UD
        • Novo Nordisk Investigational Site
      • Reading, United Kingdom, RG7 3SQ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S1 2PJ
        • Novo Nordisk Investigational Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Novo Nordisk Investigational Site
      • Suffolk, United Kingdom, IP33 1HE
        • Novo Nordisk Investigational Site
      • WAtford, United Kingdom, HA1 3UJ
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Placebo tablets for 24 weeks
Experimental: ALD 0.1
Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks
Experimental: ALD 0.25
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2004

Primary Completion (Actual)

May 4, 2005

Study Completion (Actual)

May 4, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD-1537
  • 2004-000103-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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