NCT00185224

Brief Summary

The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

First QC Date

September 10, 2005

Last Update Submit

July 14, 2011

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment

    Baseline, Cycle 7

Secondary Outcomes (1)

  • Measurement of PK parameters

    Cycle 4, Cycle 7

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Arm 2

ACTIVE COMPARATOR
Drug: SH D00264A (Triquilar)

Interventions

EV/DNG (Qlaira, BAY86-5027, SH T00658K)DRUG

7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo

Arm 1
SH D00264A (Triquilar)DRUG

7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo

Arm 2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female volunteers between 18 and 50 years requiring contraception

You may not qualify if:

  • Pregnancy or lactation
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayer Schering Pharma AG - Clin. Pharm. Berlin

Berlin, State of Berlin, 13342, Germany

Location

Related Publications (1)

  • Junge W, Mellinger U, Parke S, Serrani M. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-584. doi: 10.2165/11590220-000000000-00000.

    PMID: 21721593DERIVED

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl EstradiolNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

July 15, 2011

Record last verified: 2011-07

Locations

DE(1)