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

Phase 2CompletedNCT00196391

Duramed Research180 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Amenorrhea

Interventions

DR-2021aDRUG

1 capsule daily for 10 days

DR-2021bDRUG

1 capsule daily for 10 days

DR-2021cDRUG

1 capsule daily for 10 days

DR-2021d

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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

Time frame: Throughout study period

Secondary Outcomes

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

Time frame: Throughout study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.