Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

February 27, 2017 updated by: Novo Nordisk A/S

Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®

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)).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway
        • Novo Nordisk Investigational Site
      • Kristiansund, Norway
        • Novo Nordisk Investigational Site
      • Larvik, Norway
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0309
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7012
        • Novo Nordisk Investigational Site
  • Sweden
      • Borås, Sweden, 503 32
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 411 19
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 418 33
        • Novo Nordisk Investigational Site
      • Kungsbacka, Sweden, 434 30
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 582 20
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 582 22
        • Novo Nordisk Investigational Site
      • Norrköping, Sweden, 602 22
        • Novo Nordisk Investigational Site
      • Norrköping, Sweden, 602 32
        • Novo Nordisk Investigational Site
      • Sigtuna, Sweden, 193 30
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 111 57
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 111 37
        • Novo Nordisk Investigational Site
      • Södertälje, Sweden, 151 23
        • Novo Nordisk Investigational Site
      • Uddevalla, Sweden, 451 30
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: estradiol / norethisterone acetate
Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postmenopausal women's acceptance of bleeding
Time Frame: After 24 weeks of treatment
After 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding profile in postmenopausal women
Time Frame: After 24 weeks of treatment
After 24 weeks of treatment
Acceptance of hot flushes and breast tenderness
Time Frame: After 24 weeks of treatment
After 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2001

Primary Completion (Actual)

June 6, 2003

Study Completion (Actual)

June 6, 2003

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLIM-1408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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