NCT06535698
Completed
Not Applicable
A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.
Perelel Inc.1 site in 1 country35 target enrollmentStarted: February 19, 2024Last updated:
ConditionsWomen's Health
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Perelel Inc.
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Changes in Symptoms of Hormonal Imbalance
Overview
Brief Summary
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
- •Generally healthy without uncontrolled chronic diseases
- •Willing to avoid new hormonal balance treatments during the study
- •Consistent use of current hormonal balance treatments for at least 3 months prior to the study
Exclusion Criteria
- •Chronic conditions preventing adherence to the protocol Diabetes
- •Planned hormonal balance-related procedures during the study
- •Started any new medications or supplements that target hormonal balance in the past 3 months
- •Anyone with diabetes
- •Severe allergies requiring EpiPen
- •Pregnant, breastfeeding, or trying to conceive
- •Recent surgeries or planned surgeries during the study
- •Unwilling to follow the study protocol
Outcomes
Primary Outcomes
Changes in Symptoms of Hormonal Imbalance
Time Frame: Baseline, Week 4, Week 8, Week 12
Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.
Secondary Outcomes
- Changes in Overall Menstrual Health(Baseline, Week 4, Week 8, Week 12)
Investigators
Study Sites (1)
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