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

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Menopause
Menopausal Vasomotor Symptoms

Treatments

Drug: placebo
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00184795
2004-000103-17 (EudraCT Number)
ALD-1537

Details and patient eligibility

About

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.

Enrollment

576 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

576 participants in 3 patient groups, including a placebo group

ALD 0.1
Experimental group
Treatment:
Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
ALD 0.25
Experimental group
Treatment:
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

92

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Data sourced from clinicaltrials.gov

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