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the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction

Sponsor
Deraya University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06060691
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
4.4
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial Studying the Ameliorating Effects of Kaempferol Emulgel on Female Arousal Disorder and Sexual Dysfunction
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I

received the vaginal gel containing antioxidant extract every day for seven days. Then, the treatment continued for two months, twice weekly

Drug: Kaempferol
Kaempferol
Placebo Comparator: Group II

plain formulation

Drug: Kaempferol
Kaempferol

Outcome Measures

Primary Outcome Measures

  1. Female Sexual Function Index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Soad A. Mohamad Minya Egypt 05673

Sponsors and Collaborators

  • Deraya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deraya University
ClinicalTrials.gov Identifier:
NCT06060691
Other Study ID Numbers:
  • 5/23
First Posted:
Sep 29, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 2, 2023