Combining Dlbs 3233 with clomiphene citrate for PCOS
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
This will test whether adding Dlbs 3233 to clomiphene citrate helps women with PCOS improve insulin resistance (HOMA-IR), follicle maturation, and menstrual cycle regularity.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | N/A to 45 Years |
| Sex | Female |
| Sponsor | Inlacinpenelitian Academic / other |
| Locations | 1 site (Yogyakarta, DIY) |
| Trial ID | NCT07403201 on ClinicalTrials.gov |
What this trial studies
This interventional early-phase study gives women with PCOS either a combination of Dlbs 3233 plus clomiphene citrate or clomiphene citrate alone and monitors outcomes. Key outcomes include changes in HOMA-IR (insulin resistance), maturation of ovarian follicles, and menstrual cycle patterns. The trial is conducted at RS AMC Yogyakarta and focuses on initial safety and early signals of benefit. Results will inform whether larger trials are warranted.
Who should consider this trial
Good fit: Women of reproductive age diagnosed with PCOS who are willing to take clomiphene citrate and Dlbs 3233 and can provide informed consent are the intended participants.
Not a fit: Women who cannot take clomiphene, have other primary causes of infertility, or significant medical comorbidities may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, the combination could improve metabolic control, promote ovulation, and help regularize menstrual cycles for women with PCOS.
How similar studies have performed: Clomiphene citrate is an established ovulation agent, but combining it with Dlbs 3233 appears novel and there is limited prior published data on this exact combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * married agree to join this research Exclusion Criteria: * dis agree to join research
Where this trial is running
Yogyakarta, DIY
- RS AMC Yogyakarta — Yogyakarta, Diy, Indonesia (Recruiting)
Study contacts
- Study coordinator: prastika candra, s1
- Email: prastikacandra13@gmail.com
- Phone: 62882003145445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.