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

Sponsor
Duramed Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00196391
Collaborator
(none)
180
Enrollment
27
Locations
6
Arms
19
Duration (Months)
6.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: DR-2021a
1 capsule daily for 10 days
Other Names:
  • Micronized progesterone

    		•
    Experimental: 2

    Drug: DR-2021b
    1 capsule daily for 10 days
    Other Names:
  • Micronized Progesterone

    		•
    Experimental: 3

    Drug: DR-2021c
    1 capsule daily for 10 days
    Other Names:
  • Micronized Progesterone

    		•
    Experimental: 4

    Drug: DR-2021d
    1 capsule daily for 10 days
    Other Names:
  • Micronized Progesterone

    		•
    Experimental: 5

    Drug: DR-2021e
    1 capsule daily for 10 days
    Placebo Comparator: 6

    Other: Placebo
    1 matching placebo capsule for 10 days

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. [Throughout study period]

    Secondary Outcome Measures

    1. Time to onset, duration, and severity of withdrawal bleeding. [Throughout study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duramed Investigational Site Mobile Alabama United States 36608
    2 Duramed Investigational Site Phoenix Arizona United States 85032
    3 Duramed Investigational Site Tucson Arizona United States 85712
    4 Duramed Investigational Site Carmichael California United States 95608
    5 Duramed Investigational Site San Diego California United States 92123
    6 Duramed Investigational Site San Diego California United States 92130
    7 Duramed Investigational Site Colorado Springs Colorado United States 80909
    8 Duramed Investigational Site Pueblo Colorado United States 81001
    9 Duramed Investigational Site Gainesville Florida United States 32605
    10 Duramed Investigational Site Leesburg Florida United States 34748
    11 Duramed Investigational Site Miami Florida United States 33143
    12 Duramed Investigational Site Atlanta Georgia United States 30328
    13 Duramed Investigational Ste Dawsonville Georgia United States 30534
    14 Duramed Investigational Site Douglasville Georgia United States 30134
    15 Duramed Investigational Site Laurel Maryland United States 20707
    16 Duramed Investigational Site St. Louis Missouri United States 63110
    17 Duramed Investigational Site Alliance Nebraska United States 69301
    18 Duramed Investigational Site Lawrenceville New Jersey United States 08648
    19 Duramed Investigational Site Medford Oregon United States 97505
    20 Duramed Investigational Site Pittsburgh Pennsylvania United States 15206
    21 Duramed Investigational Site Willow Grove Pennsylvania United States 19090
    22 Duramed Investigational Site Columbia South Carolina United States 29201
    23 Duramed Investigational Site Memphis Tennessee United States 38120
    24 Duramed Investigational Site Dallas Texas United States 75390
    25 Duramed Investigational Site Houston Texas United States 77030
    26 Duramed Investigational Site Houston Texas United States 77074
    27 Duramed Investigational Site Newport News Virginia United States 23602

    Sponsors and Collaborators

    • Duramed Research

    Investigators

    • Study Chair: Duramed Protocol Chair, Duramed Research, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00196391
    Other Study ID Numbers:
    • DR-MPG-201
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Jul 30, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by , ,
    secondary amenorrhea
    progesterone
    Additional relevant MeSH terms:
    Amenorrhea
    Progesterone

    Study Results

    No Results Posted as of Jul 30, 2014