Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations (CHOICE)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184795
First received: September 13, 2005
Last updated: March 19, 2012
Last verified: March 2012
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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:
MedlinePlus related topics:
Menopause
Drug Information available for:
Estradiol
Norethindrone acetate
Norethindrone
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
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
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
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:
|
Hot flashes |
Additional relevant MeSH terms:
|
Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Norethindrone Norethindrone acetate Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 22, 2013