Treatment of Women With PCOS of Phenotype D

NCT06639698 — Not applicable, Completed, 24 participants, Lo.Li.Pharma s.r.l

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Treatment of Menstrual Cycle Alterations in Women With PCOS of Phenotype D Using Dietary Supplementation That Combines Diosgenin, Vitamin D and Alpha-lactalbumin

Registry	NCT06639698, acronym PT-PHD
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Lo.Li.Pharma s.r.l (Industry)
Conditions	PCOS (Polycystic Ovary Syndrome)
Interventions	Diosgenin (Dietary supplement)
Dates	start 2024-10-14, primary completion 2025-05-30, completion 2025-06-30, first posted 2024-10-15, last updated 2025-07-25
Locations	1 site in Italy

-Summary

In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism.

Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned.

In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Dietary Supplement: Diosgenin	Patients will take a tablet containing diosgenin (120 mg), alpha-lactalbumin (100 mg) and vitamin D (50 mcg) - two times per day for six months

Diosgenin (Dietary supplement): Patients will take a tablet containing diosgenin (120 mg), alpha-lactalbumin (100 mg) and vitamin D (50 mcg) - two times per day for six months

+Outcome measures

Primary outcomes

Restoration of regular menstrual cycle [From enrollment (T0) to the completion of the study at 6 months (T6M)]: Restoration of regular menstrual cycle will be assessed counting the days between two subsequent menstrual cycles, using a menstrual diary updated by the patients

Secondary outcomes

Restoration of physiological appearance of the ovaries at ultrasound [From enrollment (T0) to the completion of the study at 6 months (T6M)]: Reduction of the ultrasonography count of arrested ovarian follicles

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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)

+Locations (1)

Facility	City	Country	Status
Alma Res Fertility Center	Rome, ITA	Italy