NCT01596010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

May 9, 2012

Last Update Submit

March 17, 2015

Conditions

MenopauseHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the Curve (0-t)

    Up to 72 hours after trial product administration

  • Cmax, maximum concentration

    Up to 72 hours after trial product administration

Secondary Outcomes (5)

  • Time to maximum (tmax)

    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

  • Terminal half-life (t½)

    Up to 72 hours after trial product administration

  • Terminal rate constant

    Up to 72 hours after trial product administration

  • Incidence of adverse events (AEs)

    Week 8

Study Arms (2)

New formulation

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

Old formulation

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

Interventions

2 mg estradiol / 1 mg norethisterone acetate (NETA)DRUG

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.

New formulationOld formulation

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neu-Ulm, 89231, Germany

Location

Related Links

MeSH Terms

Interventions

EstradiolNorethindrone Acetate

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorethindroneNorpregnenesNorpregnanesNorsteroids

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

DE(1)