NCT01388491

Brief Summary

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

27 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

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2013

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

July 1, 2011

Results QC Date

September 23, 2013

Last Update Submit

December 1, 2021

Conditions

HemostasisOral Contraceptive

Keywords

ContraceptionHemostasisBlood Coagulation

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels

    Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.

    Baseline through Month 6

Secondary Outcomes (13)

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer

    Baseline through Month 6

  • Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen

    Baseline through Month 6

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity

    Baseline through Month 6

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin

    Baseline through Month 6

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity

    Baseline through Month 6

  • +8 more secondary outcomes

Study Arms (2)

Treatment I: (DR-102)

EXPERIMENTAL

21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles

Drug: desogestrel/ethinyl estradiol and ethinyl estradiol

Treatment II

ACTIVE COMPARATOR

21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles

Drug: desogestrel/ethinyl estradiol

Interventions

desogestrel/ethinyl estradiol and ethinyl estradiolDRUG
Treatment I: (DR-102)
desogestrel/ethinyl estradiolDRUG
Treatment II

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal, non-pregnant, non-lactating women age 18-40 years old
  • Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
  • Regular spontaneous menstrual cycle
  • Others as dictated by FDA-approved protocol

You may not qualify if:

  • Any condition which contraindicates the use of combination oral contraceptives
  • Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
  • Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
  • Others as dictated by FDA-approved protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Teva Investigational Site 32064

Essen, 45127, Germany

Location

Teva Investigational Site 32065

Frankfurt, 60311, Germany

Location

Teva Investigational Site 32066

Frankfurt am Main, 60439, Germany

Location

Teva Investigational Site 32062

Hamburg, 22159, Germany

Location

Teva Investigational Site 32063

Hamburg, 22359, Germany

Location

Teva Investigational Site 32061

Magdeburg, 39112, Germany

Location

Teva Investigational Site 80013

Giv‘atayim, 53425, Israel

Location

Teva Investigational Site 80015

Haifa, 34466, Israel

Location

Teva Investigational Site 80017

Modiin, 71705, Israel

Location

Teva Investigational Site 80014

RishonLe'zio, Israel

Location

Teva Investigational Site 80018

Tel Aviv, 62304, Israel

Location

Teva Investigational Site 80016

Tel Aviv, 69379, Israel

Location

Teva Investigational Site 30014

Brescia, 25123, Italy

Location

Teva Investigational Site 30009

Cagliari, 09124, Italy

Location

Teva Investigational Site 30012

Catania, 95123, Italy

Location

Teva Investigational Site 30013

Napoli, 80131, Italy

Location

Teva Investigational Site 30010

Pavia, 27100, Italy

Location

Teva Investigational Site 30007

Pisa, 56126, Italy

Location

Teva Investigational Site 30016

Siena, 53100, Italy

Location

Teva Investigational Site 31017

Barcelona, 08025, Spain

Location

Teva Investigational Site 31015

Barcelona, 08028, Spain

Location

Teva Investigational Site 31014

Barcelona, 08035, Spain

Location

Teva Investigational Site 31016

Gava, Barcelona, 08850, Spain

Location

Teva Investigational Site 31012

Lugo, 27002, Spain

Location

Teva Investigational Site 31010

Madrid, 28001, Spain

Location

Teva Investigational Site 31011

Madrid, 28009, Spain

Location

Teva Investigational Site 31009

Vitoria-Gasteiz, 01004, Spain

Location

Related Publications (1)

  • Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, Weiss H. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clin Exp Obstet Gynecol. 2016;43(3):334-40.

    PMID: 27328486RESULT

MeSH Terms

Conditions

Thrombosis

Interventions

DesogestrelEthinyl Estradiol

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Manager, Biopharmaceutics
Organization
Teva Pharmaceuticals USA
clinicaltrialqueries@tevausa.com
1-866-384-5525

Study Officials

  • Teva Women's Health Research Protocol Chair

    Teva Women's Health Research

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

October 31, 2011

Primary Completion

September 30, 2012

Study Completion

September 30, 2012

Last Updated

December 6, 2021

Results First Posted

November 27, 2013

Record last verified: 2021-12

Locations

IT(7)DE(6)ES(8)IL(6)