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A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

Primary Purpose

Amenorrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DR-2021a
DR-2021b
DR-2021c
DR-2021d
DR-2021e
Placebo
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring secondary amenorrhea, progesterone

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Not pregnant Secondary amenorrhea or oligomenorrhea of at least 50 days duration Not currently on any hormonal medication Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom) Exclusion Criteria: Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months Use of any hormonal birth control within the last 3 months Any contraindication to the use of progestins

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Ste
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

6

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.

Secondary Outcome Measures

Time to onset, duration, and severity of withdrawal bleeding.

Full Information

First Posted
September 13, 2005
Last Updated
July 29, 2014
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00196391
Brief Title
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
Official Title
A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
Detailed Description
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea
Keywords
secondary amenorrhea, progesterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DR-2021a
Other Intervention Name(s)
Micronized progesterone
Intervention Description
1 capsule daily for 10 days
Intervention Type
Drug
Intervention Name(s)
DR-2021b
Other Intervention Name(s)
Micronized Progesterone
Intervention Description
1 capsule daily for 10 days
Intervention Type
Drug
Intervention Name(s)
DR-2021c
Other Intervention Name(s)
Micronized Progesterone
Intervention Description
1 capsule daily for 10 days
Intervention Type
Drug
Intervention Name(s)
DR-2021d
Other Intervention Name(s)
Micronized Progesterone
Intervention Description
1 capsule daily for 10 days
Intervention Type
Drug
Intervention Name(s)
DR-2021e
Intervention Description
1 capsule daily for 10 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 matching placebo capsule for 10 days
Primary Outcome Measure Information:
Title
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Time Frame
Throughout study period
Secondary Outcome Measure Information:
Title
Time to onset, duration, and severity of withdrawal bleeding.
Time Frame
Throughout study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Not pregnant Secondary amenorrhea or oligomenorrhea of at least 50 days duration Not currently on any hormonal medication Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom) Exclusion Criteria: Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months Use of any hormonal birth control within the last 3 months Any contraindication to the use of progestins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Protocol Chair
Organizational Affiliation
Duramed Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Duramed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Duramed Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Duramed Investigational Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Duramed Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Duramed Investigational Site
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
Country
United States
Facility Name
Duramed Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Duramed Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Duramed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Duramed Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Duramed Investigational Ste
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
Duramed Investigational Site
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Duramed Investigational Site
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Duramed Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duramed Investigational Site
City
Alliance
State/Province
Nebraska
ZIP/Postal Code
69301
Country
United States
Facility Name
Duramed Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Duramed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97505
Country
United States
Facility Name
Duramed Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Duramed Investigational Site
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Duramed Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Duramed Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Duramed Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Duramed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Duramed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Duramed Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

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