Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS
- Conditions
- PCOS
- Interventions
- Drug: DingKunDan(GuangYuYuan)
- Registration Number
- NCT05872425
- Lead Sponsor
- Guangdong Women and Children Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- Women diagnosed with PCOS.
- Aged from 18 to 35 years old, in the reproductive age.
- Have not taken any hormone or Chinese medicine in the past 3 months.
- Age < 18 years or > 35 years.
- Have taken hormones or Chinese medicine in the last 3 months.
- Have congenital adrenal hyperplasia, Cushing's syndrome, or androgen-secreting tumors.
- Abnormal function of liver and kidney.
- Have hrombotic disease, arterial or venous thromboembolism, or major organic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives Drospirenone and Ethinylestradiol Tablets (Ⅱ) This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives DingKunDan(GuangYuYuan) This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). Treatment with compound oral contraceptives DingKunDan(GuangYuYuan) This arm is only treated with compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ).
- Primary Outcome Measures
Name Time Method Serum androgen Before inclusion；after one treatment course. Basic serum androgen is one of the primary outcome measure and is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Free testosterone Before inclusion；after one treatment course. Free testosterones is one of the primary outcome measureis aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Androstenedione Before inclusion；after one treatment course. Androstenedione is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
sex hormone-binding globulin（SHBG） Before inclusion；after one treatment course. SHBG is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
- Secondary Outcome Measures
Name Time Method Fasting blood-glucose (FBG) Before inclusion；after one treatment course. This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.
Fasting insulin (FINS) Before inclusion；after one treatment course. This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.
HOMA-IR Before inclusion；after one treatment course. HOMA-IR is used to assess the level of insulin resistance and help to evaluate the metabolism of individuals.
Anti-Müllerian hormone (AMH) Before inclusion；after one treatment course. AMH is an important index to evaluate AMH is an important index to evaluate the reserve function of ovarian.
HCY Before inclusion；after one treatment course. HCY is used to assess the level of folate metabolism
Trial Locations
- Locations (1)
Guangdong Women and Children Health Hospital
🇨🇳Guangzhou, Guangdong, China