NCT06800170

Treatment of Menstrual Cycle Alterations in Adolescents

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Female
• Age: 14 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.

Detailed description

The present study aims to evaluate the possible beneficial effect of a treatment with Inofolic HP combined with Inofolic phD on the improvement if menstrual cycle alteration in adolescent patients with or without PCOS. The molecules chosen for the study are the following: myo-Inositol, α-lactalbumin, Dioscorea Villosa, and Vitamin D, are already commercialized as dietary supplements, commonly administered at same dosage provided in the present study, also for prolonged treatments, with no side effects associated.

Conditions

• Amenorrhea
• Oligomenorrhea
• PCOS (Polycystic Ovary Syndrome)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	myo-Inositol plus DIoscorea Villosa	myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-01-29
• Last updated: 2026-01-06

Locations

3 sites across 3 countries: Georgia, Italy, Russia