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Completed

NCT Number: NCT00196391

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

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.

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Key information

Conditions

Amenorrhea Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-2021a

Drug

1 capsule daily for 10 days

Other names: Micronized progesterone

DR-2021b

Drug

1 capsule daily for 10 days

Other names: Micronized Progesterone

DR-2021c

Drug

1 capsule daily for 10 days

Other names: Micronized Progesterone

DR-2021d

Drug

1 capsule daily for 10 days

Other names: Micronized Progesterone

DR-2021e

Drug

1 capsule daily for 10 days

Placebo

Other

1 matching placebo capsule for 10 days

Primary outcomes

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

    Time frame: Throughout study period

Secondary outcomes

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

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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