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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184795

Acronym

CHOICE

Enrollment

576

Registered

2005-09-16

Start date

2004-05-28

Completion date

2005-05-04

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Vasomotor Symptoms, Menopause

Keywords

Hot flashes

Brief summary

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.

Interventions

DRUG0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

One tablet per day for 24 weeks

DRUG0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

One tablet per day for 24 weeks

DRUGplacebo

Placebo tablets for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in mean number of moderate to severe hot flushes per week	At week 8

Secondary

Measure	Time frame
Vaginal cytology and pH	Week 0; week 24
Bleeding profile	Week 0; week 24
Urogenital symptoms	Week 0; week 24
Menopausal symptoms and quality of life (Greene Climacteric Scale)	Week 0; week 24
Hot flush weekly weighted score	Week 0; week 24
Adverse Events	Week 0; week 24

Countries

Austria, Belgium, Denmark, Finland, France, Germany, Norway, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026