Clinical trial NCT01705249: Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women
Official title: Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 191
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)).


Eligibility 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

Primary outcomes:
measure: Postmenopausal women's acceptance of bleeding
timeFrame: After 24 weeks of treatment
Secondary outcomes:
measure: Bleeding profile in postmenopausal women
timeFrame: After 24 weeks of treatment
measure: Acceptance of hot flushes and breast tenderness
timeFrame: After 24 weeks of treatment
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Novo Nordisk Investigational Site
city: Kristiansund
country: Norway
facility: Novo Nordisk Investigational Site
city: Larvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Borås
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kungsbacka
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Norrköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Norrköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Sigtuna
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Södertälje
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uddevalla
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: