Clinical trial · Interventional
Diamel in the Treatment of Polycystic Ovary Syndrome
Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome
NCT01051024CI-TRIAL-00006850completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diamel | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Diamel
- interventionNames
- Dietary Supplement: Diamel
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (5)
- measure
- Normalization of blood concentrations of androgens at week 24
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Two of the following criteria: * Oligo or Anovulation * Polycystic Ovary diagnosed by ultrasound technique * Clinical signs of Hyperandrogenism * Signed informed consent Exclusion Criteria: * Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism. * Patients under other experimental treatment * Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment * Treatment with vitamins within 7 days before treatment * Treatment with dietary supplements within 60 days before treatment * Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension
References
Publications (0)
Data not yet available
No reference posted for this study.