NCT00915915

Brief Summary

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

May 18, 2009

Last Update Submit

October 27, 2014

Conditions

ContraceptionOvulation Inhibition

Keywords

Female contraceptionOvulation inhibition

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

    4 months

Secondary Outcomes (5)

  • The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

    4 months

  • Course of gonadotropins (FSH, LH, P, E2)

    4 months

  • Endometrial thickness and Follicle size

    4 months

  • Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3

    4 Months

  • Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3

    4 Months

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Arm 2

EXPERIMENTAL
Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Interventions

Ethinylestradiol/Gestodene (BAY86-5016)DRUG

Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Arm 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 18 BMI 30 kg/m²
  • Healthy female volunteers
  • Age 18-35 years (smoker not older than 30 years, inclusive)
  • Ovulatory pre-treatment cycle, at least 3 month since delivery
  • Abortion or lactation before the first screening examination
  • Willingness to use non-hormonal methods of contraception during entire study

You may not qualify if:

  • Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
  • Regular intake of medication other than OCs
  • Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Related Links

MeSH Terms

Interventions

Ethinyl EstradiolGestodene

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

June 8, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

DE(2)