Treatment of Menstrual Cycle Alterations in Adolescents

Not Applicable

Not yet recruiting

• Conditions: Amenorrhea; Oligomenorrhea; PCOS (Polycystic Ovary Syndrome)

• Registration Number: NCT06800170
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief 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.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Start: 2025-05-01
• Primary Completion: 2025-08-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea

Exclusion Criteria

• Primary amenorrhea.
• Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).
• Hyperprolactinemia or overt hypothyroidism (TSH ≥4).
• Other hormonal alterations.
• Ongoing hormonal therapies, including OCPs, six months before enrollment.
• Ongoing pharmacological therapies.
• Ongoing use of myo-Inositol supplement or other source of myo-Inositol, or Dioscorea villosa, six months before enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Menstrual cycle regularity	6 months	The intervention is targed to adolescent patients suffering from menstrual cycle alterations. Particularly, we aim to asses the regularization of the menstrual cycle in those patients with polimenhorrea and oligo-/ amenorrhea, with irregular menstrual cycle (shorter than 21 days or longer than 35 days).; The purpose of the study is to compare the percentage of patients exhibiting a regular menstrual cycle at the end of the treatment period, in the study group vs control.