Clinical trial · Interventional
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
NCT01733459CI-TRIAL-00033989completedPhase 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)
This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.
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 (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DLBS3233 | Drug | — | UNRESOLVED |
| Metformin XR | Drug | Metformin | ALIAS |
| Placebo caplet of Metformin XR | Drug | — | UNRESOLVED |
| Placebo capsule of DLBS3233 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment I
- description
- 1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
- interventionNames
- Drug: DLBS3233
- Drug: Placebo caplet of Metformin XR
- type
- ACTIVE_COMPARATOR
- label
- Treatment II
- description
- 1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
- interventionNames
- Drug: Metformin XR
- Drug: Placebo capsule of DLBS3233
Primary outcomes (1)
- measure
- HOMA-IR reduction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects in reproductive age (i.e. 18-40 years) * Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the Rotterdam Criteria * Subject with insulin resistance defined by: HOMA-IR of \> 2.00 Exclusion Criteria: * Pregnant and lactating women * Subjects known to have Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia * Known to have current medical condition, which, is judged by the Investigator could jeopardize subject's health or interfere with the study evaluation, such as diabetes mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic infections, and any known malignancies * Impaired renal function (serum creatinine level \> 1.5 ULN) * Impaired liver function (serum ALT level ≥ 2.5 ULN) * Medically-assisted weight loss with medications or surgical procedures * Currently having laparoscopic ovarian diathermy (LOD) * Currently under treatment with in vitro fertilization (IVF) techniques * Have been regularly taking any medications which affect insulin sensitivity as well as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior to screening * Participating in other clinical trial within 30 days prior to screening
References
Publications (1)
- DERIVEDHestiantoro A, Permadi W, Tjandrawinata RR, Wiweko B, Ritonga MA, Ferrina AI, Sumapraja K, Muharam R, Djuwantono T. The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):35-47. doi: 10.22074/ijfs.2023.551350.1283. PMID 39033369