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

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ClinicalTrials.gov Identifier: NCT01705249
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
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)).

Condition or disease Intervention/treatment Phase
Menopause Healthy Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®
Actual Study Start Date : August 14, 2001
Actual Primary Completion Date : June 6, 2003
Actual Study Completion Date : June 6, 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol

Arm Intervention/treatment
Experimental: estradiol / norethisterone acetate Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
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 Outcome Measures :
  1. Postmenopausal women's acceptance of bleeding [ Time Frame: After 24 weeks of treatment ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705249


Locations
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Norway
Novo Nordisk Investigational Site
Kristiansand, Norway
Novo Nordisk Investigational Site
Kristiansund, Norway
Novo Nordisk Investigational Site
Larvik, Norway
Novo Nordisk Investigational Site
Oslo, Norway, 0309
Novo Nordisk Investigational Site
Trondheim, Norway, NO-7012
Sweden
Novo Nordisk Investigational Site
Borås, Sweden, 503 32
Novo Nordisk Investigational Site
Göteborg, Sweden, 411 19
Novo Nordisk Investigational Site
Göteborg, Sweden, 418 33
Novo Nordisk Investigational Site
Kungsbacka, Sweden, 434 30
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85
Novo Nordisk Investigational Site
Linköping, Sweden, 582 20
Novo Nordisk Investigational Site
Linköping, Sweden, 582 22
Novo Nordisk Investigational Site
Norrköping, Sweden, 602 22
Novo Nordisk Investigational Site
Norrköping, Sweden, 602 32
Novo Nordisk Investigational Site
Sigtuna, Sweden, 193 30
Novo Nordisk Investigational Site
Stockholm, Sweden, 111 37
Novo Nordisk Investigational Site
Stockholm, Sweden, 111 57
Novo Nordisk Investigational Site
Södertälje, Sweden, 151 23
Novo Nordisk Investigational Site
Uddevalla, Sweden, 451 30
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01705249     History of Changes
Other Study ID Numbers: KLIM-1408
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone Acetate
Hormones
Estradiol
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral