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NCT01705249 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01705249
Other study ID # KLIM-1408
Secondary ID
Status Completed
Phase Phase 4
First received October 8, 2012
Last updated February 27, 2017
Start date August 14, 2001
Est. completion date June 6, 2003

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)).

Recruitment information / eligibility
Status Completed
Enrollment 191
Est. completion date June 6, 2003
Est. primary completion date June 6, 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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®.

Locations
Country Name City State
Norway Novo Nordisk Investigational Site Kristiansand
Norway Novo Nordisk Investigational Site Kristiansund
Norway Novo Nordisk Investigational Site Larvik
Norway Novo Nordisk Investigational Site Oslo
Norway Novo Nordisk Investigational Site Trondheim
Sweden Novo Nordisk Investigational Site Borås
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Kungsbacka
Sweden Novo Nordisk Investigational Site Linköping
Sweden Novo Nordisk Investigational Site Linköping
Sweden Novo Nordisk Investigational Site Linköping
Sweden Novo Nordisk Investigational Site Norrköping
Sweden Novo Nordisk Investigational Site Norrköping
Sweden Novo Nordisk Investigational Site Sigtuna
Sweden Novo Nordisk Investigational Site Södertälje
Sweden Novo Nordisk Investigational Site Stockholm
Sweden Novo Nordisk Investigational Site Stockholm
Sweden Novo Nordisk Investigational Site Uddevalla

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postmenopausal women's acceptance of bleeding After 24 weeks of treatment
Secondary Bleeding profile in postmenopausal women After 24 weeks of treatment
Secondary Acceptance of hot flushes and breast tenderness After 24 weeks of treatment
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