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
  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) ] [ 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.

  Eligibility

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.

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

Locations
Norway
Rud, Norway, 1309
Sweden
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marta Kokot-Kierepa Novo Nordisk Health Care AG
  More Information

Additional Information:
No publications provided

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: June 17, 2013
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on April 16, 2014