AmenorrheaHP-phD_AdolescNCT06800170
Treatment of Menstrual Cycle Alterations in Adolescents
A study testing myo-Inositol plus DIoscorea Villosa in people with Amenorrhea and Oligomenorrhea, run by Lo.Li.Pharma s.r.l at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Amenorrhea, Oligomenorrhea, PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- myo-Inositol plus DIoscorea Villosa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2025to 2 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Georgia1 site
Zhordania and Khomasuridze Institute of Reproductology
Tbilisi, Georgia, 0112
Russia1 site
Department of Obstetrics and Gynecology with Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education
Saint Petersburg, Russian Federation
About this study
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.
Read the detailed 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.
- Conditions
- Amenorrhea, Oligomenorrhea, PCOS (Polycystic Ovary Syndrome)
- Being tested
- myo-Inositol plus DIoscorea Villosa
- Keywords
- myo-Inositol, Dioscorea Villosa, adolescents
- Medical subject headings
- Amenorrhea, Oligomenorrhea, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-Inositol plus DIoscorea VillosaDietary supplement
Also called myo-Inositol, Dioscorea Villosa
myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily
| Study group | Role | What they receive |
|---|---|---|
| Treated Group HP+phD | Experimental | Not described Receives: Dietary Supplement: myo-Inositol plus DIoscorea Villosa |
| Controls | No intervention | Not treated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jun 2025
- Primary completion2 Feb 2026
- Study completion2 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Vittorio Unfer, AGUNCO Obstetrics and Gynecology Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800170
- Sponsor's protocol ID
- HP+phD in adolescents
- Acronym
- HP-phD_Adolesc
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Menstrual Cycle Alterations in Adolescents
- ClinicalTrials.gov ID
- NCT06800170
- Acronym / sponsor ID
- HP-phD_Adolesc / HP+phD in adolescents
- Conditions
- Amenorrhea, Oligomenorrhea, PCOS (Polycystic Ovary Syndrome)
- Keywords
- myo-Inositol, Dioscorea Villosa, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Group HP+phD | Experimental | Dietary Supplement: myo-Inositol plus DIoscorea Villosa |
| Controls | No intervention | –Not treated patients |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myo-Inositol plus DIoscorea VillosaAlso: myo-Inositol, Dioscorea Villosamyo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily | Dietary supplement | Treated Group HP+phD |
Primary outcome
Menstrual cycle regularity
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myo-Inositol plus DIoscorea Villosa in people with Amenorrhea and Oligomenorrhea, run by Lo.Li.Pharma s.r.l at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual cycle regularity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.