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OpenTrials
Completed

NCT Number: NCT01705249

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

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)).

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Key information

Conditions

Menopause Healthy

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Kristiansand, Norway

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)

Drug

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®.

Primary outcomes

  1. Postmenopausal women's acceptance of bleeding

    Time frame: After 24 weeks of treatment

Secondary outcomes

  1. Bleeding profile in postmenopausal women

    Time frame: After 24 weeks of treatment

  2. Acceptance of hot flushes and breast tenderness

    Time frame: After 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Oct 12, 2012
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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