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Recruiting NCT07403201

The Effect of Therapy Combination in PCOS With Dlbs 3233

Early Phase I Interventional Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dlbs 3233 , clomifen citrat.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: up to 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Combination Therapy Dlbs 3233 and Clomifen Citrate vs Clomifen Citrate on Homa ir, Maturation Follicle, and Menstrual Cycle in PCOS Cases at Muhammadiyah Asri Medical Center Hospital

Overview

The effect of combination therapy dlbs 3233 and clomifen citrate vs clomifen citrate on homa ir, maturation follicle, and menstrual cycle in PCOS cases at Muhammadiyah Asri Medical Center Hospital

Detailed description

to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss

Interventions

  • Combination product dlbs 3233 , clomifen citrat
    combination theraphy

Primary outcome measures

  • Change in HOMA-IR [Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)]
  • Change in serum AMH concentration [Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)]
Secondary outcome measures (4)
  • Change in total follicle count on Day 12 ultrasound [Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)]
  • Change in number of mature follicles on Day 12 ultrasound [Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)]
  • Change in mature follicle diameter on Day 12 ultrasound [Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)]
  • Menstrual cycle regularity during the 3-month treatment period [Time frame: During the 3-month treatment period]

Eligibility criteria

Inclusion criteria

  • married agree to join this research

Exclusion criteria

  • dis agree to join research

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • RS AMC Yogyakarta — Yogyakarta

Identifiers

NCT: NCT07403201 · Inlacinpenelitian

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗