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Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076621
First Posted: February 26, 2010
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.

Condition Intervention
Menopause Postmenopausal Bleeding Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 12 Month Non-interventional (Observational), International, Multi-centre, Prospective Study to Evaluate the Bleeding Pattern of Ultra-low Dose Continuous Combined Hormone Replacement Therapy Containing 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate (Eviana®)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Bleeding profile during the 52 weeks of treatment with 0.5 mg estradiol and 0.1 mg norethisterone acetate evaluated by bleeding, and bleeding or spotting rates [ Time Frame: At every lunar month (28 days) ]

Secondary Outcome Measures:
  • Change in bleeding profile [ Time Frame: During the 52 weeks of treatment ]
  • Change in mean number of hot flushes per week [ Time Frame: During the 52 weeks of treatment ]

Enrollment: 176
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Data collection of the use of 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) in women in connection to a daily clinical practice.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The postmenopausal women (who are ammenorrheic) are to be offered participation in the study at the discretion of the treating physician following the decision to prescribe 0.5 mg estradiol and 0.1 mg norethisterone acetate for the treatment of their menopausal symptoms.
Criteria

Inclusion Criteria:

  • Informed consent, permitting the data to be processed within the scope of the study, is obtained from the patient before any study-related activities
  • Postmenopausal amenorrhoeic women
  • Treatment with previously combined HRT discontinued at least 3 months prior to start of 0.5 mg estradiol and 0.1 mg norethisterone acetate treatment
  Contacts and Locations
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): NCT01076621


Locations
Norway
Rud, Norway, 1309
Sweden
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076621     History of Changes
Other Study ID Numbers: ALD-3795
U1111-1112-8626 ( Other Identifier: WHO )
First Submitted: February 25, 2010
First Posted: February 26, 2010
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral