Treatment for women with a specific type of PCOS
Treatment of Menstrual Cycle Alterations in Women with PCOS of Phenotype D Using Dietary Supplementation That Combines Diosgenin, Vitamin D and Alpha-lactalbumin
NA · Lo.Li.Pharma s.r.l · NCT06639698
This study is testing a dietary supplement to see if it can help women with a specific type of PCOS get their menstrual cycles back on track and improve their ovarian health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Lo.Li.Pharma s.r.l (industry) |
| Locations | 1 site (Rome, ITA) |
| Trial ID | NCT06639698 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on female patients diagnosed with PCOS of phenotype D, characterized by menstrual cycle alterations and normal androgen levels. Participants will receive a dietary supplement containing Dioscorea extract, vitamin D, and alpha-lactalbumin for six months. The primary goal is to restore regular menstrual cycles and improve the ultrasound appearance of the ovaries, addressing the limitations of current treatments for this phenotype. The study aims to evaluate the efficacy of this natural approach in managing symptoms of PCOS phenotype D.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with PCOS of phenotype D who meet the inclusion criteria.
Not a fit: Patients with other phenotypes of PCOS, hormonal treatments, or significant metabolic alterations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing symptoms of PCOS phenotype D without the side effects of traditional hormonal therapies.
How similar studies have performed: While there is limited data on the specific use of Diosgenin for this phenotype, other studies exploring natural supplements for PCOS have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and the EGOI-PCOS Criteria Exclusion Criteria: * Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria * Hormonal treatments; * Treatments with inositol or other insulin sensitizers (such as metformin); * Insulin resistance or pre-diabetes condition * BMI \> 30 * Endocrinological alterations * Chronic pharmacological therapies * Major pathological conditions (e.g. tumors or autoimmune diseases)
Where this trial is running
Rome, ITA
- Alma Res Fertility Center — Rome, ITA, Italy (RECRUITING)
Study contacts
- Study coordinator: Cesare Aragona
- Email: aragonacesare@gmail.com
- Phone: +39 348 4043527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PCOS, PCOS phenotype D, Diosgenin, Dioscorea