Female Sexual DysfunctionPhase 1NCT06060691
the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction
A Phase 1 study testing Kaempferol in people with Female Sexual Dysfunction, run by Deraya University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 28 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Kaempferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2023to 1 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 28 and 45
- had regular periods and previous menstrual bleeding lasted between three and seven days
Who cannot join
- sensitivity to drug of therapy,
- cancer,
- autoimmune illness,
- smoking or drinking,
- liver disease,
- irregular menstruation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Female Sexual Dysfunction
- Being tested
- Kaempferol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaempferolDrug
Kaempferol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Kaempferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start20 Sep 2023
- Primary completion30 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060691
- Sponsor's protocol ID
- 5/23
- Status last verified
- May 2024
- First submitted
- 24 Sep 2023
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Studying the Ameliorating Effects of Kaempferol Emulgel on Female Arousal Disorder and Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT06060691
- Acronym / sponsor ID
- 5/23
- Conditions
- Female Sexual Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kaempferol group | Experimental | Drug: KaempferolKaempferol gel received the vaginal gel containing antioxidant extract every day for seven days. Then, the treatment continued for two months, twice weekly |
| Placebo group | Placebo comparator | Drug: KaempferolPlain formulation received the vaginal gel containing antioxidant extract every day for seven days. Then, the treatment continued for two months, twice weekly |
Who may qualify
- Ages
- 28 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between the ages of 28 and 45
- had regular periods and previous menstrual bleeding lasted between three and seven days
Key exclusion criteria (6 listed)
- sensitivity to drug of therapy,
- cancer,
- autoimmune illness,
- smoking or drinking,
- liver disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KaempferolKaempferol | Drug | Kaempferol group, Placebo group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kaempferol in people with Female Sexual Dysfunction, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.