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Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS

NCT05872425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-30

No results posted yet for this study

Summary

This is a single-center, non-randomized, open-label clinical study to investigate the efficacy and safety of Dingkundan (DKP) combined with compound oral contraceptives (COC) in the treatment of PCOS. This study is mainly to compare the effect of COC plus DKP verse COC on reducing androgen, improving the function of ovarian and the individual metabolism. The secondary objective of our study is to explore the efficacy of DKP on pregnancy in patients with PCOS and its safety.

Conditions

  • PCOS

Interventions

DRUG

DingKunDan(GuangYuYuan)

The experimental group would be given DingKunDan, the subjects should take 3.5g each time, twice a day. Subjects in the control group only needed to take COC. Both groups take medicine for 3 months consecutively as a course of treatment.

DRUG

Drospirenone and Ethinylestradiol Tablets (Ⅱ)

The experimental group and the control group would be given oral Drospirenone and Ethinylestradiol Tablets (Ⅱ). According to the packaging instructions, on the first day of menstruation, according to the packaging instructions, the subjects should take the tablet, then take the rest sequential at the same time every day for 28 consecutive days, menstruation would happen after drug withdrawal (or after 7 days of drug withdrawal), and the next medication cycle begin on the first day of menstruation.

Sponsors & Collaborators

  • Guangdong Women and Children Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872425 on ClinicalTrials.gov