NCT07403201

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2021

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

November 24, 2021

Last Update Submit

February 4, 2026

Conditions

Polycystic Ovary Syndrome

Keywords

pcosdlbbs 3233clomifen citrat

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Baseline cycle (Day 12) to Month 3 cycle (Day 12)

  • Change in number of mature follicles on Day 12 ultrasound

    Baseline cycle (Day 12) to Month 3 cycle (Day 12)

  • Change in mature follicle diameter on Day 12 ultrasound

    Baseline cycle (Day 12) to Month 3 cycle (Day 12)

  • Menstrual cycle regularity during the 3-month treatment period

    During the 3-month treatment period

Other Outcomes (3)

  • Change in body mass index (BMI) during treatment

    Baseline to 3 months

  • Change in ovarian volume on ultrasound during annual follow-up

    Up to 5 years (annual follow-up)

  • Change in BMI during annual follow-up

    Up to 5 years (annual follow-up)

Study Arms (2)

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

Combination Product: dlbs 3233 , clomifen citrat

Interventions

dlbs 3233 , clomifen citratCOMBINATION_PRODUCT

combination theraphy

The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS

Eligibility Criteria

AgeUp to 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • married agree to join this research

You may not qualify if:

  • dis agree to join research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS AMC Yogyakarta

Yogyakarta, DIY, 55253, Indonesia

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • UMY Yogyakarta

    muhammadiyah university of yogyakarta

    STUDY DIRECTOR

Central Study Contacts

prastika candra, s1

CONTACT

62882003145445prastikacandra13@gmail.com

nazdifah fitriyani, s1

CONTACT

6282223338737nadzifahfitri37@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

February 11, 2026

Study Start

December 15, 2021

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)