Brief Summary

This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).

Trial Health

On Track

Trial Health Score

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

Enrollment

191

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Aug 2001

Geographic Reach

2 countries

19 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

1.8 years study duration

Study Start

First participant enrolled

August 14, 2001

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2003

Completed

9.3 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed

Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

October 8, 2012

Last Update Submit

February 27, 2017

Conditions

Menopause Healthy

Outcome Measures

Primary Outcomes (1)

Postmenopausal women's acceptance of bleeding
After 24 weeks of treatment

Secondary Outcomes (2)

Bleeding profile in postmenopausal women
After 24 weeks of treatment
Acceptance of hot flushes and breast tenderness
After 24 weeks of treatment

Study Arms (1)

estradiol / norethisterone acetate

EXPERIMENTAL

Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)

Interventions

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

After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.

estradiol / norethisterone acetate

Eligibility Criteria

Age50 Years+

Sexfemale

Healthy VolunteersYes

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

You may qualify if:

Healthy women
At least 3 months on Trisekvens® before screening period
Ability to understand and comply with the protocol requirements

You may not qualify if:

Less than 12 months or more than 36 months postmenopausal judged by the Investigator
Known, suspected, or past history of hormone dependent tumor/cancers
Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions
Ischemic heart disease or myocardial infarction within 6 months prior to randomization

Contact the study team to confirm eligibility.