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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: February 22, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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 ]

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

Enrollment: 576
Actual Study Start Date: May 28, 2004
Study Completion Date: May 4, 2005
Primary Completion Date: May 4, 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   (Adult)
Sexes 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

  Show 92 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184795     History of Changes
Other Study ID Numbers: ALD-1537
2004-000103-17 ( EudraCT Number )
Study First Received: September 13, 2005
Last Updated: February 22, 2017

Keywords provided by Novo Nordisk A/S:
Hot flashes

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

ClinicalTrials.gov processed this record on July 21, 2017