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

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.

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

Conditions
-----------------
Amenorrhea

Intervention / Treatment
-----------------
* Drug: DR-2021a
* Drug: DR-2021b
* Drug: DR-2021c
* Drug: DR-2021d
* Drug: DR-2021e
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-2021a<br>* 1 capsule daily for 10 days<br>* Other names: Micronized progesterone;|
| Experimental: 2<br> | Drug: DR-2021b<br>* 1 capsule daily for 10 days<br>* Other names: Micronized Progesterone;|
| Experimental: 3<br> | Drug: DR-2021c<br>* 1 capsule daily for 10 days<br>* Other names: Micronized Progesterone;|
| Experimental: 4<br> | Drug: DR-2021d<br>* 1 capsule daily for 10 days<br>* Other names: Micronized Progesterone;|
| Experimental: 5<br> | Drug: DR-2021e<br>* 1 capsule daily for 10 days<br>|
| Placebo Comparator: 6<br> | Other: Placebo<br>* 1 matching placebo capsule for 10 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. |  | Throughout study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset, duration, and severity of withdrawal bleeding. |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secondary amenorrhea, progesterone