Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05872425 |
| Other study ID # |
GuangdongWCH-LiLi |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Guangdong Women and Children Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
In this study, the decreased level of serum androgen was used as the main outcome index. It
was assumed that PCOS patients treated with Dingkundan combined with compound oral
contraceptives for 3 menstrual cycles had decreased serum androgen by 0.53nmol/L. It was
assumed that the serum androgen decreased by 0.21nmol/L after 3 menstrual cycles of combined
oral contraceptives alone. If α = 0.05, the test degree was 80%, and the dropout rate of 20%,
considering that the sample size ratio between the experimental group and control group was
1, the sample size of experimental group and control group were 60 cases each, and 120 cases
in total. All the samples were recruited from the Department of Gynecology and Women's Health
Care of Guangdong Women and Children's Health Hospital.
This study was approved by the Ethics Committee of the hospital, and all participants are
required to sign informed consent.
Before the study, researchers should be trained in a unified and standardized manner,
including medication methods, observation indicators, judgment and treatment of adverse
reactions/events, and reporting of serious adverse events.
The researcher must adequately and accurately record the research process so that the
research data can be verified. These records can be divided into two categories: study
documents and raw patient data. Study documents include protocols and amendments, sample
informed consent forms, researcher resumes and authorization forms, and other required
documents and correspondence. Original documents of patients' include patient
inpatient/outpatient records, doctor's and nurse's orders, appointment dates, original
laboratory reports, ultrasound, signed informed consent forms, patient screening forms, etc.
During the study period, if the subject withdraws the informed consent, or refuses the
further follow-up, or loses follow-up, or dies, the sample will be disqualified.
If the subject withdraws consent, refuses to continue the study, or the investigator
determines that the subject's clinical symptoms/physical condition has worsened and that the
subject is no longer suitable for the study, or the subject develops toxicity intolerance,
such as any clinical AE, laboratory abnormalitiesor, or the investigator determines that the
subject has reached the study endpoint, or any circumstances warrant discontinuation of this
study judged by the investigator, or the study sponsor discontinues the study, this study
will be stop.
Anyway, this clinical study is conducted in accordance with the Declaration of Helsinki and
relevant regulations on clinical trials in China. It can only be carried out after obtaining
the approval of the Ethics Committee. The modification of clinical research protocols,
informed documents and other materials involved in clinical research should be approved by
the Ethics Committee before implementation. The investigator should protect the rights and
privacy of the subject.
