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

Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS: an Open-label, Non-randomized Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: PCOS
• Intervention / Treatment: Drug: DingKunDan(GuangYuYuan); Drug: Drospirenone and Ethinylestradiol Tablets (Ⅱ)

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Women and Children Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives; This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ).	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.; Other Names: DingKunDan(GuangYuYuan): Z20059003; Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972; 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.; Other Names: Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972
Active Comparator: Treatment with compound oral contraceptives; This arm is only treated with compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ).	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.; Other Names: DingKunDan(GuangYuYuan): Z20059003; Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum androgen	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.	Before inclusion；after one treatment course.
Free testosterone	Free testosterones is one of the primary outcome measureis aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.	Before inclusion；after one treatment course.
Androstenedione	Androstenedione is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.	Before inclusion；after one treatment course.
sex hormone-binding globulin（SHBG）	SHBG is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.	Before inclusion；after one treatment course.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood-glucose (FBG)	This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.	Before inclusion；after one treatment course.
Fasting insulin (FINS)	This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.	Before inclusion；after one treatment course.
HOMA-IR	HOMA-IR is used to assess the level of insulin resistance and help to evaluate the metabolism of individuals.	Before inclusion；after one treatment course.
Anti-Müllerian hormone (AMH)	AMH is an important index to evaluate AMH is an important index to evaluate the reserve function of ovarian.	Before inclusion；after one treatment course.
HCY	HCY is used to assess the level of folate metabolism	Before inclusion；after one treatment course.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction	Adverse reaction is used to assess the safety level of DingKunDan. Adverse reactions were reported by the patient, such as nausea, vomiting, decreased appetite, irregular uterine bleeding, and breast tenderness.	3 months after one treatment course.
Liver function	Liver function is used to assess the safety level of DingKunDan. Liver function includes the level of ALT, AST, ALT/AST by blood test.	3 months after one treatment course.
Kidney function	Kidney function is used to assess the safety level of DingKunDan. Kidney function includes the level of Urea, CO2, CRE, UA, β2-MG by blood test.	3 months after one treatment course.

Collaborators and Investigators

• Sponsor: Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: PCOS; Dingkundan(DKP); Compound Oral Contraceptives(COC)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Natriuretic Agents; Diuretics; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Ethinyl Estradiol; Drospirenone; Drospirenone and ethinyl estradiol combination
• Other Study ID Numbers: GuangdongWCH-LiLi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No