Treatment of Menstrual Cycle Alterations in Adolescents

Last updated: January 5, 2026
Sponsor: Lo.Li.Pharma s.r.l
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Amenorrhea

Dysfunctional Uterine Bleeding

Treatment

myo-Inositol plus DIoscorea Villosa

Clinical Study ID

NCT06800170
HP+phD in adolescents
  • Ages 14-19
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Primary amenorrhea.

  • Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushingsyndrome).

  • 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 Dioscoreavillosa, six months before enrollment.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: myo-Inositol plus DIoscorea Villosa
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Zhordania and Khomasuridze Institute of Reproductology

    Tbilisi 611717, Georgia 0112
    Georgia

    Active - Recruiting

  • Zhordania and Khomasuridze Institute of Reproductology

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Agunco

    Rome 3169070, Italy 00155
    Italy

    Active - Recruiting

  • Agunco

    Rome, 00155
    Italy

    Site Not Available

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

    Saint Petersburg 498817, Russian Federation
    Russia

    Active - Recruiting

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

    Saint Petersburg,
    Russian Federation

    Site Not Available

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