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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184795
First received: September 13, 2005
Last updated: December 19, 2016
Last verified: December 2016

September 13, 2005
December 19, 2016
May 2004
May 2005   (final data collection date for primary outcome measure)
Change in mean number of moderate to severe hot flushes per week [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
Change in mean number of moderate to severe hot flushes per week at week 8
Complete list of historical versions of study NCT00184795 on ClinicalTrials.gov Archive Site
  • Urogenital symptoms [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Vaginal cytology and pH [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Bleeding profile [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Menopausal symptoms and quality of life (Greene Climacteric Scale) [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Hot flush weekly weighted score [ Time Frame: Week 0; week 24 ] [ Designated as safety issue: No ]
  • Hot flush weekly weighted score
  • Bleeding profile
  • Menopausal symptoms and quality of life (Greene Climacteric Scale)
  • Urogenital symptoms
  • Vaginal cytology and pH
Not Provided
Not Provided
 
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Menopause
  • Menopausal Vasomotor Symptoms
  • Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
    One tablet per day for 24 weeks
  • Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
    One tablet per day for 24 weeks
  • Drug: placebo
    Placebo tablets for 24 weeks
  • Experimental: ALD 0.1
    Intervention: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
  • Experimental: ALD 0.25
    Intervention: Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Female
45 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Norway,   Sweden,   Switzerland,   United Kingdom
 
NCT00184795
ALD-1537, 2004-000103-17
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Irek Otulski, MD Novo Nordisk RE
Study Director: Robert Gut, MD, PhD Novo Nordisk RE
Novo Nordisk A/S
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP