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

Phase 4

Completed

• Conditions: Healthy; Menopause
• Interventions: Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)

• Registration Number: NCT01705249
• Lead Sponsor: Novo Nordisk A/S

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)).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08-14
• Primary Completion: 2003-06-06
• Study Completion: 2003-06-06
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 191

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
estradiol / norethisterone acetate	1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)	-

Primary Outcome Measures

Name	Time	Method
Postmenopausal women's acceptance of bleeding	After 24 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Uddevalla, Sweden