Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Official Title
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Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

Conditions
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Secondary Amenorrhea

Intervention / Treatment
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* Drug: PROMETRIUM® 300 mg
* Drug: PROMETRIUM® 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with secondary amenorrhea Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine Exclusion Criteria: Primary amenorrhea Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome) Peanut allergy Allergy to progestational steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PROMETRIUM® 300 mg<br>* 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles<br>|
| Active Comparator: 2<br> | Drug: PROMETRIUM® 400 mg<br>* 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secretory Conversion of the Endometrium | Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria. | End of the study (Days 85) | 
| Number of Subjects With Withdrawal Bleeding | This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle. | After first and second cycle (cycle=28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Intensity of Withdrawal Bleeding After Any Cycle | The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy | Duration of withdrawal bleed | 
| The Duration of Withdrawal Bleeding After the First Treatment Cycle | The numbers of days the subjects actually bled after the end of the first treatment cycle. | End of the first cycle of treatment (cycle=28 days) | 
| The Duration of Withdrawal Bleeding After Second Treatment Cycle | The numbers of days the subjects actually bled after the end of the second treatment cycle | End of the second cycle of treatment (cycle=28 days) | 
| Time to Withdrawal Bleeding After First Treatment Cycle | The number of days between the first cycle of treatment and the withdrawal bleeding. | End of the first cycle of treatment (cycle=28 days) | 
| Time to Withdrawal Bleeding After Second Treatment Cycle | The number of days between the second cycle of treatment and the withdrawal bleeding | End of the second cycle of treatment (cycle=28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea