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The purpose of this study is to determine the safety of SRX251 when given orally. The amount of SRX251 in the blood will also be measured. Healthy women, ages 18-50 years who have been surgically sterilized by tubal ligation, will be enrolled in this study.
Vasopressin appears to be a key mediating factor in menstrual pain. This position stems from findings that the hormone, arginine vasopressin (AVP), causes constriction of uterine blood vessels which in turn produces congestion of the uterus resulting in dysmenorrhea. Prior to menses, blood vessels in the uterine wall become engorged with blood. Elevated concentrations of vasopressin acting through V1a receptors cause constriction of both uterine and vascular smooth muscle, contributing to the discomfort and pain of primary dysmenorrhea. Consequently, blockade of these receptors with a selective V1a receptor antagonist would be expected to provide therapeutic benefits to women with primary dysmenorrhea.
SRX251 is a new chemical entity with potent V1a receptor antagonist properties, and an acceptable safety profile as demonstrated in preclinical studies. This study is intended to evaluate the safety and pharmacokinetic profile of a single oral dose of SRX251 in healthy human female volunteers in preparation for further studies of the safety and pharmacological activity in the amelioration of pain associated with primary dysmenorrhea.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRX251 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| safety | duration of protocol |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | duration of protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benno G Roesch, MD | Advanced Biomedical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Biomedical Research, Inc. | Hackensack | New Jersey | 07601 | United States |
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