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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184795
First received: September 13, 2005
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Menopause
Menopausal Vasomotor Symptoms
Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in mean number of moderate to severe hot flushes per week [ Time Frame: At week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urogenital symptoms [ Designated as safety issue: No ]
  • Vaginal cytology and pH [ Designated as safety issue: No ]
  • Bleeding profile [ Designated as safety issue: No ]
  • Adverse Events [ Designated as safety issue: No ]
  • Menopausal symptoms and quality of life (Greene Climacteric Scale) [ Designated as safety issue: No ]
  • Hot flush weekly weighted score [ Designated as safety issue: No ]

Enrollment: 576
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: placebo
Placebo tablets for 24 weeks

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184795

Locations
Austria
Vienna, Austria
Belgium
Leuven, Belgium
Denmark
Odense, Denmark
Finland
Helsinki, Finland
France
Nantes, France
Germany
Tübingen, Germany
Norway
Trondheim, Norway
Sweden
Gothenburg, Sweden
Switzerland
Zürich, Switzerland
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Irek Otulski, MD Novo Nordisk RE
Study Director: Robert Gut, MD, PhD Novo Nordisk RE
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184795     History of Changes
Other Study ID Numbers: ALD-1537, 2004-000103-17
Study First Received: September 13, 2005
Last Updated: March 19, 2012
Health Authority: France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Austria: Federal Ministry for Health and Women
Switzerland: Swissmedic
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novo Nordisk A/S:
Hot flashes

Additional relevant MeSH terms:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Norethindrone
Norethindrone acetate
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014