NCT01291004

Brief Summary

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 31, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2012

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

February 4, 2011

Last Update Submit

December 1, 2021

Conditions

Follicle DevelopmentOvarian FollicleFollicle CountFollicle SizeOral Contraceptive

Outcome Measures

Primary Outcomes (4)

  • Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.

    16 weeks

  • Change in serum Estradiol level from baseline to week 16.

    16 weeks

  • Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.

    16 weeks

  • Change in serum Progesterone level from baseline to week 20.

    20 weeks

Secondary Outcomes (13)

  • Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.

    15 weeks

  • Change from baseline to week 15 in D-dimer.

    15 weeks

  • Change from baseline to end of week 15 in Plasmin-Antiplasmin complex

    15 weeks

  • Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).

    15 weeks

  • Change from baseline to week 15 in Fibrinogen.

    15 weeks

  • +8 more secondary outcomes

Study Arms (3)

28-day Desogestrel Oral Contraceptive

EXPERIMENTAL
Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol

28-day Drospirenone Oral Contraceptive

ACTIVE COMPARATOR
Drug: 28-day drospirenone oral contraceptive

28-day Levonorgestrel Oral Contraceptive

ACTIVE COMPARATOR
Drug: 28-day levonorgestrel oral contraceptive

Interventions

Desogestrel/ethinyl estradiol and ethinyl estradiolDRUG

Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet

28-day Desogestrel Oral Contraceptive
28-day drospirenone oral contraceptiveDRUG

Drospirenone/ethinyl estradiol 0.3/0.02 mg

28-day Drospirenone Oral Contraceptive
28-day levonorgestrel oral contraceptiveDRUG

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

28-day Levonorgestrel Oral Contraceptive

Eligibility Criteria

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

You may qualify if:

  • Premenopausal, non-pregnant, non-lactating women age 18-35 years old
  • Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
  • Regular spontaneous menstrual cycle
  • Others as dictated by Food and Drug Administration (FDA)-approved protocol

You may not qualify if:

  • Any condition which contraindicates the use of combination oral contraceptives
  • Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
  • Migraine headaches with focal, neurological symptoms
  • Others as dictated by FDA-approved protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Teva Investigational Site 10119

Philadelphia, Pennsylvania, 19114, United States

Location

Teva Investigational Site 10118

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

DesogestrelEthinyl Estradiol

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Teva Women's Health Research Protocol Chair

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 7, 2011

Study Start

January 31, 2011

Primary Completion

March 31, 2012

Study Completion

March 31, 2012

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations

US(2)