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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Healthy; Menopause

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01705249

KLIM-1408

Details and patient eligibility

About

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)).

Enrollment: 191 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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191 participants in 1 patient group

estradiol / norethisterone acetate

Experimental group

Treatment:

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