NCT00184795|CompletedPhase 3

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

CHOICE

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

ALD-15372004-000103-17

Study Type

interventional

Target

576

Locations

10 countries

Sites

Timeline

RegisteredSep 2005

StartedMay 2004

CompletionMay 2005

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

576

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach

10 countries

91 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

May 28, 2004

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2005

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed

Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

September 13, 2005

Last Update Submit

February 22, 2017

Conditions

Menopause Menopausal Vasomotor Symptoms

Keywords

Hot flashes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

Urogenital symptoms
Week 0; week 24
Vaginal cytology and pH
Week 0; week 24
Bleeding profile
Week 0; week 24
Adverse Events
Week 0; week 24
Menopausal symptoms and quality of life (Greene Climacteric Scale)
Week 0; week 24
+1 more secondary outcomes

Study Arms (3)

ALD 0.1

EXPERIMENTAL

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

ALD 0.25

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)DRUG

One tablet per day for 24 weeks

ALD 0.1

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)DRUG

One tablet per day for 24 weeks

ALD 0.25

placeboDRUG

Placebo tablets for 24 weeks

Placebo

Eligibility Criteria

Age45 Years - 65 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.