NCT06060691

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

September 24, 2023

Last Update Submit

May 15, 2024

Conditions

Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index

    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

Study Arms (2)

Kaempferol group

EXPERIMENTAL

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

Drug: Kaempferol

Placebo group

PLACEBO COMPARATOR

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

Drug: Kaempferol

Interventions

KaempferolDRUG

Kaempferol

Kaempferol groupPlacebo group

Eligibility Criteria

Age28 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale has sexual problems
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 28 and 45
  • had regular periods and previous menstrual bleeding lasted between three and seven days

You may not qualify if:

  • sensitivity to drug of therapy,
  • cancer,
  • autoimmune illness,
  • smoking or drinking,
  • liver disease,
  • irregular menstruation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, 05673, Egypt

Location

MeSH Terms

Interventions

kaempferol

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

September 20, 2023

Primary Completion

December 30, 2023

Study Completion

February 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)