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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01076621
First received: February 25, 2010
Last updated: June 17, 2013
Last verified: June 2013

February 25, 2010
June 17, 2013
May 2010
June 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Bleeding profile during the 52 weeks of treatment with Eviana® evaluated by bleeding, and bleeding or spotting rates [ Time Frame: at every lunar month (28 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01076621 on ClinicalTrials.gov Archive Site
  • Change in bleeding profile [ Time Frame: During the 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in mean number of hot flushes per week [ Time Frame: During the 52 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months
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®)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Menopause
  • Postmenopausal Bleeding
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.
A
Intervention: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT01076621
ALD-3795, U1111-1112-8626
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Marta Kokot-Kierepa Novo Nordisk Health Care AG
Novo Nordisk A/S
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP