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Hormone Therapy
KSHN001126 for Healthy Postmenopausal Women
Phase 1
Waitlist Available
Research Sponsored by Shivanka Research, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-menopausal females defined as either 12 months off menstrual period after the age of 50 years, or 12 months off menstrual period after the age of 40 years and Follicle Stimulating Hormone (FSH) > 40 mIU/mL. Amenorrhea not due to lactation
Participants with normal findings as determined by gynecological examination and USG Pelvis
Must not have
Pregnant or lactating female participant
The participant is surgically induced postmenopausal female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto day 15 after dosing
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called KSHN001126 on healthy post-menopausal women to see how safe it is and how the body processes it. The main goal is to check for
Who is the study for?
This trial is for healthy post-menopausal women who are willing to participate in a study evaluating the safety of a new drug. Specific eligibility criteria details were not provided.
What is being tested?
The trial tests three different doses (150mg, 300mg, and 600mg) of KSHN001126 to see how safe they are and how the body processes them. It's an open-label study where everyone knows what treatment they're getting.
What are the potential side effects?
Potential side effects aren't specified but generally could include reactions at the dose site, gastrointestinal symptoms, headaches, or fatigue as common with oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a post-menopausal woman not having periods due to age or hormone levels.
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My recent pelvic exam and ultrasound results were normal.
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I am not pregnant or breastfeeding.
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I can provide blood samples as needed for the study.
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I am a healthy woman aged 45-60 and have gone through menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
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I am postmenopausal due to surgery.
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I have a history of osteoporosis or a condition that affects bone health.
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I have a condition that worsens with estrogen, like breast cancer.
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I have not had a vaccine 2 weeks before or will not during the study.
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I have previously used hormone replacement therapy.
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I have not donated blood or lost more than 250 mL of blood in the last 60 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto day 15 after dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto day 15 after dosing
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with abnormal Electrocardiogram readings
Number of participants with abnormal laboratory tests results
Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: KSHN001126 600mgExperimental Treatment1 Intervention
High Dose
Group II: KSHN001126 300mgExperimental Treatment1 Intervention
Mid Dose
Group III: KSHN001126 150mgExperimental Treatment1 Intervention
Low Dose
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Shivanka Research, LLCLead Sponsor
Eric Solutions LLCUNKNOWN
Clinexcel Research, Ahmedabad, IndiaUNKNOWN
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