A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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
Arms & Interventions
1
Intervention: DR-2021a (Drug)
2
Intervention: DR-2021b (Drug)
3
Intervention: DR-2021c (Drug)
4
Intervention: DR-2021d (Drug)
5
Intervention: DR-2021e (Drug)
6
Intervention: Placebo (Other)
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.(Throughout study)