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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Amenorrhea

Treatments: Other: Placebo; Drug: DR-2021b; Drug: DR-2021a; Drug: DR-2021d; Drug: DR-2021c; Drug: DR-2021e

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196391

DR-MPG-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 6 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DR-2021a

2

Experimental group

Treatment:

Drug: DR-2021b

3

Experimental group

Treatment:

Drug: DR-2021c

4

Experimental group

Treatment:

Drug: DR-2021d

5

Experimental group

Treatment:

Drug: DR-2021e

6

Placebo Comparator group

Treatment:

Other: Placebo