RecruitingNot ApplicableNCT06800170

Treatment of Menstrual Cycle Alterations in Adolescents


Sponsor

Lo.Li.Pharma s.r.l

Enrollment

20 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 14 YearsMax Age: 19 Years

Inclusion Criteria1

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

Exclusion Criteria7

  • 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.

Interventions

DIETARY_SUPPLEMENTmyo-Inositol plus DIoscorea Villosa

myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily


Locations(3)

Zhordania and Khomasuridze Institute of Reproductology

Tbilisi, Georgia, Georgia

Agunco

Rome, Italy, Italy

Department of Obstetrics and Gynecology with Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education

Saint Petersburg, Russian Federation, Russia

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NCT06800170


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