Efficacy and Safety of Dingkundan Combined With Compound Oral Contraceptives in the Treatment of PCOS: an Open-label, Randomized Controlled Study

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single-center, 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Women and Children Hospital
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol

Criteria

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.