the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction
May 15, 2024 updated by: Deraya University
Randomized Controlled Trial Studying the Ameliorating Effects of Kaempferol Emulgel on Female Arousal Disorder and Sexual Dysfunction
The aim of this study is to evaluate the quality of sexual life of females with sexual interest or arousal disorder before and after accurate application of a formulated emulgel made from natural ingredients, including kaempferol as an API
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Minya, Egypt, 05673
- Soad A. Mohamad
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women between the ages of 28 and 45
- had regular periods and previous menstrual bleeding lasted between three and seven days
Exclusion Criteria:
- sensitivity to drug of therapy,
- cancer,
- autoimmune illness,
- smoking or drinking,
- liver disease,
- irregular menstruation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kaempferol group
Kaempferol gel received the vaginal gel containing antioxidant extract every day for seven days.
Then, the treatment continued for two months, twice weekly
|
Kaempferol
|
|
Placebo Comparator: Placebo group
Plain formulation received the vaginal gel containing antioxidant extract every day for seven days.
Then, the treatment continued for two months, twice weekly
|
Kaempferol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Index
Time Frame: two months
|
The FSFI comprises 19 questions of sexual function in six independent areas consisting of desire, arousal, lubrication, orgasm, sexual satisfaction , pain from sex.
|
two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2023
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
September 24, 2023
First Submitted That Met QC Criteria
September 24, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 15, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 5/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.