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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: February 25, 2010
Last updated: October 24, 2014
Last verified: October 2014
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
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.


Genders 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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076621

Rud, Norway, 1309
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
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 
Study First Received: February 25, 2010
Last Updated: October 24, 2014
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on May 25, 2016