Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
NCT ID: NCT01596010
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2007-10-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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New formulation
2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Old formulation
2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Interventions
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2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Eligibility Criteria
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Inclusion Criteria
* Non-smoking
* Body Mass Index (BMI) maximum 35.0 kg/m\^2
* Able to understand, read and speak German fluently
* Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
* Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration
Exclusion Criteria
* Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
* Known, suspected or history of breast cancer
* Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
* Abnormal genital bleeding of unknown aetiology
* Known insulin dependent as well as non-insulin dependent diabetes mellitus
* Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C
* Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated
50 Years
70 Years
FEMALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Neu-Ulm, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-003350-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KLI-1915
Identifier Type: -
Identifier Source: org_study_id
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