Safety and Efficacy of Formulation for Improving Vagina Laxity: A Pilot Study (NCT05710536) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy of Formulation for Improving Vagina Laxity: A Pilot Study
Stopped: sponsor discontinued
Malaysia18 participantsStarted 2023-12-01
Plain-language summary
This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome and licorice root extract in improving vagina laxity (VL) condition of women in Malaysia. This formulation may stimulate cell rejuvenation and trigger cell renewal efficiently as they contained rich mixture of natural, bioavailable polypeptides and plant extracts and these might help improving the VL condition in women. The study duration is 5 weeks and vagina assessment will be carried out at baseline, week 2 and week 5.The main objectives of this study are:
1. To assess the vagina laxity of women in Malaysia after using the formulation.
2. To observe any adverse effect occurrence with the use of the formulation.
Who can participate
Age range
40 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Malaysian women ( age 40 to 55 years old)
* Complaint of vagina laxity
* Willingness to participate in the study
Exclusion Criteria:
* Pregnant and breastfeeding women
* Doing any surgical or non-surgical procedures to improved vaginal laxity condition such as laser and radiofrequency before participating in the study that might affect the study outcome
* Presence of illness or taking any medication that might impact the study outcome or participants well-being
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product
Timeframe: Baseline, Week 2 and Week 5
2
Change in vagina tone from baseline and at week 2 and week 5 after using the product