Treatment of Menstrual Cycle Alterations in Adolescents

ConditionsAmenorrhea Oligomenorrhea PCOS (Polycystic Ovary Syndrome)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age14-19

SponsorLo.Li.Pharma s.r.l

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Primary amenorrhea.

Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).

Hyperprolactinemia or overt hypothyroidism (TSH ≥4).

Other hormonal alterations.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Treated Group HP+phDExperimental treatment 1 intervention

Group B: ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

Menstrual cycle regularity

The intervention is targed to adolescent patients suffering from menstrual cycle alterations. Particularly, we aim to asses the regularization of the menstrual cycle in those patients with polimenhorrea and oligo-/ amenorrhea, with irregular menstrual cycle (shorter than 21 days or longer than 35 days). The purpose of the study is to compare the percentage of patients exhibiting a regular menstrual cycle at the end of the treatment period, in the study group vs control.

Time frame

6 months