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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06800170
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