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Completed
NCT06800170
Treatment of Menstrual Cycle Alterations in Adolescents
Conditions: Amenorrhea, Oligomenorrhea, PCOS (Polycystic Ovary Syndrome)
Sex: Female
Ages: 14 Years – 19 Years
Healthy volunteers: No
Phase: NA
Enrollment: 41
Sponsor: Lo.Li.Pharma s.r.l
Location: Zhordania and Khomasuridze Institute of Reproductology Tbilisi Georgia
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 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.
Source: ClinicalTrials.gov (NCT06800170). StuddyBuddy aggregates publicly available trial information.
