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

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ClinicalTrials.gov Identifier: NCT01076621
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Menopause Postmenopausal Bleeding Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Study Design
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Study Type : Observational
Actual Enrollment : 176 participants
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®)
Study Start Date : May 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Change in bleeding profile [ Time Frame: During the 52 weeks of treatment ]
  2. Change in mean number of hot flushes per week [ Time Frame: During the 52 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Norway
Rud, Norway, 1309
Sweden
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076621    
Other Study ID Numbers: ALD-3795
U1111-1112-8626 ( Other Identifier: WHO )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Norethindrone
Norethindrone Acetate
Estradiol
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