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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00196391
Enrollment
180
Registered
2005-09-20
Start date
2005-09-30
Completion date
2007-04-30
Last updated
2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea

Keywords

secondary amenorrhea, progesterone

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.

Interventions

DRUGDR-2021a

1 capsule daily for 10 days

DRUGDR-2021b

1 capsule daily for 10 days

DRUGDR-2021c

1 capsule daily for 10 days

DRUGDR-2021d

1 capsule daily for 10 days

DRUGDR-2021e

1 capsule daily for 10 days

OTHERPlacebo

1 matching placebo capsule for 10 days

Sponsors

Duramed Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.Throughout study period

Secondary

MeasureTime frame
Time to onset, duration, and severity of withdrawal bleeding.Throughout study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026