## Protocol Section
### Identification Module
**NCT ID:** NCT00362479

**Brief Title:** Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

**Official Title:** A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

#### Organization Study ID Info
**ID:** DR-DSG-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Teva Branded Pharmaceutical Products R&D, Inc.
### Status Module
#### Completion Date
**Date:** 2007-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-08-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-07

**Type:** ACTUAL

#### Start Date
**Date:** 2006-08

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2006-08-10
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-09
**Study First Submit QC Date:** 2006-08-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Duramed Research

#### Responsible Party

**Old Name Title:** Duramed Protocol Chair

**Old Organization:** Duramed Research, Inc.

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

**Detailed Description:** The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

### Conditions Module

**Conditions:**

- Contraception

**Keywords:**

- pregnancy prevention

- oral contraceptives

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1347

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: DR-1021

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 1 tablet daily

**Name:** DR-1021

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Evaluation of pregnancy rates

**Time Frame:** Duration of study

#### Secondary Outcomes

**Measure:** Adverse events reported by patients and investigators

**Time Frame:** Duration of study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Sexually active at risk of pregnancy

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Huntsville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Alabama

**Zip:** 35801

**Location 2:**

**City:** Mobile

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Alabama

**Zip:** 36608

**Location 3:**

**City:** Phoenix

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Arizona

**Zip:** 85015

**Location 4:**

**City:** Phoenix

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Arizona

**Zip:** 85031

**Location 5:**

**City:** Carmichael

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** California

**Zip:** 95608

**Location 6:**

**City:** Irvine

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** California

**Zip:** 92618

**Location 7:**

**City:** San Diego

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** California

**Zip:** 92108

**Location 8:**

**City:** San Diego

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** California

**Zip:** 92123

**Location 9:**

**City:** San Ramon

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** California

**Zip:** 94583

**Location 10:**

**City:** Colorado Springs

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Colorado

**Zip:** 80909

**Location 11:**

**City:** Lakewood

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Colorado

**Zip:** 80228

**Location 12:**

**City:** Wilmington

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Delaware

**Zip:** 19805

**Location 13:**

**City:** Washington

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** District of Columbia

**Zip:** 20006

**Location 14:**

**City:** Aventura

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33180

**Location 15:**

**City:** Boynton Beach

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33437

**Location 16:**

**City:** Brooksville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33613

**Location 17:**

**City:** Clearwater

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33761

**Location 18:**

**City:** Coral Gables

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33134

**Location 19:**

**City:** Fort Meyers

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33918

**Location 20:**

**City:** Leesburg

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 34748

**Location 21:**

**City:** Longwood

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 32779

**Location 22:**

**City:** Miami

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33173

**Location 23:**

**City:** Pinellas Park

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33781

**Location 24:**

**City:** Sarasota

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 34239

**Location 25:**

**City:** St. Petersburg

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33702

**Location 26:**

**City:** St. Petersburg

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33709

**Location 27:**

**City:** Tampa

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33613

**Location 28:**

**City:** West Palm Beach

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Florida

**Zip:** 33409

**Location 29:**

**City:** Atlanta

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Georgia

**Zip:** 30328

**Location 30:**

**City:** Atlanta

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Georgia

**Zip:** 30342

**Location 31:**

**City:** Decatur

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Georgia

**Zip:** 30034

**Location 32:**

**City:** Roswell

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Georgia

**Zip:** 30075

**Location 33:**

**City:** Boise

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Idaho

**Zip:** 83704

**Location 34:**

**City:** Chicago

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Illinois

**Zip:** 60611

**Location 35:**

**City:** Chicago

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Illinois

**Zip:** 60612

**Location 36:**

**City:** Peoria

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Illinois

**Zip:** 61602

**Location 37:**

**City:** Shawnee Mission

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Kansas

**Zip:** 66216

**Location 38:**

**City:** Topeka

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Kansas

**Zip:** 66614

**Location 39:**

**City:** Lexington

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Kentucky

**Zip:** 40509

**Location 40:**

**City:** Louisville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Kentucky

**Zip:** 40291

**Location 41:**

**City:** Mt Sterling

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Kentucky

**Zip:** 40353

**Location 42:**

**City:** Kansas City

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Missouri

**Zip:** 64108

**Location 43:**

**City:** Lincoln

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Nebraska

**Zip:** 68510

**Location 44:**

**City:** Las Vegas

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Nevada

**Zip:** 89146

**Location 45:**

**City:** Moorestown

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** New Jersey

**Zip:** 08057

**Location 46:**

**City:** New Brunswick

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** New Jersey

**Zip:** 08901

**Location 47:**

**City:** Albuquerque

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** New Mexico

**Zip:** 87102

**Location 48:**

**City:** Johnson City

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** New York

**Zip:** 13790

**Location 49:**

**City:** Rochester

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** New York

**Zip:** 14609

**Location 50:**

**City:** Charlotte

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** North Carolina

**Zip:** 28211

**Location 51:**

**City:** Raleigh

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** North Carolina

**Zip:** 27612

**Location 52:**

**City:** Wilmington

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** North Carolina

**Zip:** 28412

**Location 53:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** North Carolina

**Zip:** 27103

**Location 54:**

**City:** Columbus

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Ohio

**Zip:** 43210

**Location 55:**

**City:** Columbus

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Ohio

**Zip:** 43213

**Location 56:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Oklahoma

**Zip:** 73112

**Location 57:**

**City:** Medford

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Oregon

**Zip:** 97504

**Location 58:**

**City:** Philadelphia

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Pennsylvania

**Zip:** 19114

**Location 59:**

**City:** Reading

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Pennsylvania

**Zip:** 19606

**Location 60:**

**City:** Cranston

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Rhode Island

**Zip:** 02920

**Location 61:**

**City:** Greer

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** South Carolina

**Zip:** 29651

**Location 62:**

**City:** Mt Pleasant

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** South Carolina

**Zip:** 29464

**Location 63:**

**City:** Bristol

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 37620

**Location 64:**

**City:** Chattanooga

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 37404

**Location 65:**

**City:** Clarksville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 37043

**Location 66:**

**City:** Germantown

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 38138

**Location 67:**

**City:** Knoxville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 37920

**Location 68:**

**City:** Nashville

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Tennessee

**Zip:** 37203

**Location 69:**

**City:** Austin

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Texas

**Zip:** 78759

**Location 70:**

**City:** Dallas

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Texas

**Zip:** 75234

**Location 71:**

**City:** Houston

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Texas

**Zip:** 77030

**Location 72:**

**City:** San Antonio

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Texas

**Zip:** 78229

**Location 73:**

**City:** Waco

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Texas

**Zip:** 76712

**Location 74:**

**City:** Magna

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Utah

**Zip:** 84044

**Location 75:**

**City:** Pleasant Grove

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Utah

**Zip:** 84062

**Location 76:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Utah

**Zip:** 84124

**Location 77:**

**City:** Sandy

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Utah

**Zip:** 84070

**Location 78:**

**City:** Arlington

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Virginia

**Zip:** 22203

**Location 79:**

**City:** Newport News

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Virginia

**Zip:** 23602

**Location 80:**

**City:** Norfolk

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Virginia

**Zip:** 23507

**Location 81:**

**City:** Richmond

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Virginia

**Zip:** 23233

**Location 82:**

**City:** Lakewood

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Washington

**Zip:** 98499

**Location 83:**

**City:** Seattle

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Washington

**Zip:** 98105

**Location 84:**

**City:** Spokane

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Washington

**Zip:** 99207

**Location 85:**

**City:** Tacoma

**Country:** United States

**Facility:** Duramed Investigational Site

**State:** Washington

**Zip:** 98405

#### Overall Officials

**Official 1:**

**Affiliation:** Duramed Research

**Name:** Duramed Medical Monitor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
