Analysis of the status of clinical trial registration for contraceptives based on WHO International Clinical Trials Registry Platform
10.3760/cma.j.cn101441-20250131-00044
- VernacularTitle:基于WHO国际临床试验注册平台的全球避孕药具临床试验注册现状分析
- Author:
Mingjun YANG
1
;
Fang TIAN
1
;
Xin ZHANG
1
;
Minjie XIA
1
;
Jingying HU
1
;
Weihua LI
1
;
Daxu FU
1
Author Information
1. 上海市生物医药技术研究院 国家卫生健康委员会计划生育药具重点实验室 上海生殖健康药具工程技术研究中心，上海 200032
- Publication Type:Journal Article
- Keywords:
Contraception;
Clinical trial;
World Health Organization;
International Clinical Trials Registry Platform;
Registration status
- From:
Chinese Journal of Reproduction and Contraception
2025;45(7):720-724
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the registration status of clinical trials related to contraceptives based on the data of World Health Organization International Clinical Trials Registry Platform (ICTRP), so as to understand the situation of contraceptives development, and provide reference for improving the quality of clinical trials.Methods:All records in the database of ICTRP before January 1, 2025 was researched to screen out contraceptives clinical trials, and the registration time, registration platform, regional distribution, trial design and research content were analyzed.Results:A total of 206 clinical trials related to contraceptives were included. The projects were mainly carried out in the United States, Germany, and India. About 95.63% (197/206) of the study subjects were women of reproductive age. The main type of study was intervention [89.32% (184/206)], among which random trials accounted for 53.26% (98/184), and parallel group trials were the most common [82.65% (81/98)]. Over 64.56% (133/206) of the trials were indicated with open-label. Most of the clinical trials were in phase Ⅲ [47.57% (98/206)] and phase Ⅳ [16.50% (34/206)]. The interventions in female studies were mainly in three aspects: oral contraceptive [42.64% (84/197)], intrauterine delivery [15.23% (30/197)], and vaginal delivery [15.23% (30/197)], and the primary outcome included pregnancy rate [54.82% (108/197)], adverse drug reactions [13.20% (26/197)], ovulation inhibition [8.63% (17/197)], and vaginal infection [4.06% (8/197)].Conclusion:The clinical trials of contraceptives were unevenly distributed, the research types were mainly randomized interventional trials, the included participants were mainly women of reproductive age, the intervention measures were mostly oral contraceptive, intrauterine delivery and vaginal delivery.
