CTRI/2017/06/008791
Completed
Phase 2
An open label, multi-center, prospective clinical study to Evaluation of Efficacy and Safety of JPF-16 Capsules in Sexual Dysfunction in Females - NI
Chatarubhuj Pharmaceutical Co0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Female Sexual Dysfunction
- Sponsor
- Chatarubhuj Pharmaceutical Co
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of Female Sexual Interest/Arousal Disorder according to the DSM\-5 criteria (2013\)
- •2\. Be involved in a stable relationship and have a partner
- •3\. Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria
- •1\.Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes
- •2\.Subjects with history of major psychiatric disorder
- •3\.Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
- •4\.Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
Outcomes
Primary Outcomes
Not specified
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