Overview

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

Status:
Completed
Trial end date:
2003-06-06
Target enrollment:
0
Participant gender:
Female
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)).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Hormones
Norethindrone
Norethindrone Acetate
Polyestradiol phosphate
Criteria
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