Polycystic Ovary SyndromeEarly Phase 1NCT07403201
The Effect of Therapy Combination in PCOS With Dlbs 3233
A Early Phase 1 study testing dlbs 3233 , clomifen citrat in people with Polycystic Ovary Syndrome, run by Inlacinpenelitian at 1 site in Indonesia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- dlbs 3233 , clomifen citrat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Dec 2021to 31 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- married agree to join this research
Who cannot join
- dis agree to join research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
RS AMC Yogyakarta
Yogyakarta, DIY, 55253
rs amc yogyakarta, 6274618400, inlacinpenelitian2021@gmail.com
amc yogyakarta, 628170618400
About this study
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
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
Read the detailed description
to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- dlbs 3233 , clomifen citrat
- Keywords
- pcos, dlbbs 3233, clomifen citrat
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dlbs 3233 , clomifen citratCombination product
combination theraphy
| Study group | Role | What they receive |
|---|---|---|
| Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta | No intervention | to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient |
| The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS | Experimental | To compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first Receives: Combination Product: dlbs 3233 , clomifen citrat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HOMA-IR
HOMA-IR will be used to assess insulin resistance. Fasting glucose and fasting insulin will be collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment, and HOMA-IR will be calculated as a single index value.
Measured: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
Change in serum AMH concentration
Serum anti-mullerian hormone (AMH) will be measured from venous blood collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment to assess ovarian function response.
Measured: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
Secondary outcomes (4)
Change in total follicle count on Day 12 ultrasound
Total number of follicles will be assessed by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.
Measured: Baseline cycle (Day 12) to Month 3 cycle (Day 12)
Change in number of mature follicles on Day 12 ultrasound
Number of mature follicles assessed by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.
Measured: Baseline cycle (Day 12) to Month 3 cycle (Day 12)
Change in mature follicle diameter on Day 12 ultrasound
Mature (dominant) follicle diameter will be measured by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.
Measured: Baseline cycle (Day 12) to Month 3 cycle (Day 12)
Menstrual cycle regularity during the 3-month treatment period
Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period.
Measured: During the 3-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Dec 2021
- Primary completion31 Jan 2026
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inlacinpenelitian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- UMY Yogyakarta, Study director, muhammadiyah university of yogyakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403201
- Sponsor's protocol ID
- Inlacinpenelitian
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2021
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07403201
- Acronym / sponsor ID
- Inlacinpenelitian
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- pcos, dlbbs 3233, clomifen citrat
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- InlacinpenelitianUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 11 Feb 2026 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta | No intervention | –to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient |
| The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS | Experimental | Combination Product: dlbs 3233 , clomifen citratTo compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- married agree to join this research
Key exclusion criteria (1 listed)
- dis agree to join research
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 |
|---|---|---|
| dlbs 3233 , clomifen citratcombination theraphy | Combination product | The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS |
Primary outcome
Change in HOMA-IR
Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
HOMA-IR will be used to assess insulin resistance. Fasting glucose and fasting insulin will be collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment, and HOMA-IR will be calculated as a single index value.
Change in serum AMH concentration
Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
Serum anti-mullerian hormone (AMH) will be measured from venous blood collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment to assess ovarian function response.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
UMY Yogyakarta study director
muhammadiyah university of yogyakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing dlbs 3233 , clomifen citrat in people with Polycystic Ovary Syndrome, run by Inlacinpenelitian at 1 site in Indonesia.
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 1 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact prastika candra, s1 (62882003145445, prastikacandra13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HOMA-IR (time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)). The study lists 2 primary outcomes in all. 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 11 Feb 2026.