Treatment of Menstrual Cycle Alterations in Adolescents

Launched by LO.LI.PHARMA S.R.L · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how two natural treatments, Myo-Inositol and Dioscorea Villosa, can help improve irregular menstrual cycles in adolescent girls, especially those who have conditions like Polycystic Ovary Syndrome (PCOS) or experience infrequent periods (known as oligomenorrhea) or no periods at all (known as amenorrhea). The goal is to see if these treatments can help restore more regular menstrual cycles for young women aged 14 to 19 who have already started their periods for at least three years.

To participate in the study, girls must be within that age range and experiencing either infrequent periods or no periods. However, those who have never had a period, have certain hormonal disorders, or are currently taking specific medications or supplements related to menstrual health are not eligible. If you join the study, you can expect to be part of a program that evaluates how these treatments might improve your menstrual cycle, contributing to a better understanding of menstrual health in young women. The study is not yet recruiting participants, so you would need to wait for it to start.

Gender

FEMALE

Eligibility criteria

• 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.