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OpenTrials
Completed

NCT Number: NCT00184795

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

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.

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Key information

Conditions

Menopause Hot Flashes Menopausal Vasomotor Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Placebo tablets for 24 weeks

Primary outcomes

  1. Change in mean number of moderate to severe hot flushes per week

    Time frame: At week 8

Secondary outcomes

  1. Urogenital symptoms

    Time frame: Week 0; week 24

  2. Vaginal cytology and pH

    Time frame: Week 0; week 24

  3. Bleeding profile

    Time frame: Week 0; week 24

  4. Adverse Events

    Time frame: Week 0; week 24

  5. Menopausal symptoms and quality of life (Greene Climacteric Scale)

    Time frame: Week 0; week 24

  6. Hot flush weekly weighted score

    Time frame: Week 0; week 24

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: CHOICE

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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