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Clinical Trials/NCT01596010
NCT01596010CompletedPhase 1

Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone

Novo Nordisk A/S0 sites44 target enrollmentStarted: October 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
44
Primary Endpoint
Area under the Curve (0-t)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
  • •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

  • •Known or suspected allergy to trial products or related products
  • •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

Arms & Interventions

New formulation

Experimental

Intervention: 2 mg estradiol / 1 mg norethisterone acetate (NETA) (Drug)

Old formulation

Active Comparator

Intervention: 2 mg estradiol / 1 mg norethisterone acetate (NETA) (Drug)

Outcomes

Primary Outcomes

Area under the Curve (0-t)

Time Frame: Up to 72 hours after trial product administration

Cmax, maximum concentration

Time Frame: Up to 72 hours after trial product administration

Secondary Outcomes

  • Incidence of adverse events (AEs)(Week 8)
  • Terminal rate constant(Up to 72 hours after trial product administration)
  • Area under the curve from time zero to infinity(Up to 72 hours after trial product administration)
  • Time to maximum (tmax)(Up to 72 hours after trial product administration)
  • Terminal half-life (t½)(Up to 72 hours after trial product administration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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