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Clinical Trials/NCT01076621
NCT01076621
Completed
Not Applicable

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®)

Novo Nordisk A/S0 sites176 target enrollmentMay 2010
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ConditionsMenopausePostmenopausal Bleeding
Interventions0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Drugs0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Overview

Phase
Not Applicable
Intervention
0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Conditions
Menopause
Sponsor
Novo Nordisk A/S
Enrollment
176
Primary Endpoint
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
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
June 2013
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Arms & Interventions

A

Intervention: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in bleeding profile(During the 52 weeks of treatment)
  • Change in mean number of hot flushes per week(During the 52 weeks of treatment)

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