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

NCT05872425 | Completed

• 1 other identifier: GuangdongWCH-LiLi
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

Dingkundan(DKP); Compound Oral Contraceptives(COC); PCOS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Fasting blood-glucose (FBG)

  Before inclusion；after one treatment course.

• Fasting insulin (FINS)

  Before inclusion；after one treatment course.

• HOMA-IR

  Before inclusion；after one treatment course.

• Anti-Müllerian hormone (AMH)

  Before inclusion；after one treatment course.

• HCY

  Before inclusion；after one treatment course.

Other Outcomes (3)

• Adverse reaction

  3 months after one treatment course.

• Liver function

  3 months after one treatment course.

• Kidney function

  3 months after one treatment course.

Study Arms (2)

Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives

EXPERIMENTAL

This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ).

Drug: DingKunDan(GuangYuYuan); Drug: Drospirenone and Ethinylestradiol Tablets (Ⅱ)

Treatment with compound oral contraceptives

ACTIVE COMPARATOR

This arm is only treated with compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ).

Drug: DingKunDan(GuangYuYuan)

Interventions

DingKunDan(GuangYuYuan) DRUG

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.

Also known as: DingKunDan(GuangYuYuan): Z20059003, Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972

Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives; Treatment with compound oral contraceptives

Drospirenone and Ethinylestradiol Tablets (Ⅱ) DRUG

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.

Also known as: Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972

Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Health Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

drospirenone; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Institute of Women's and Children's Health

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 24, 2023
• Study Start: February 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)