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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Information source: Regenex Pharmaceutical, China
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Contraceptive

Intervention: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg (Drug); Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Regenex Pharmaceutical, China

Official(s) and/or principal investigator(s):
Chengliang Xiong, Dr, Principal Investigator, Affiliation: Family Planning Research Institute of TJMC,HUST

Overall contact:
Chengliang Xiong, Dr, Email: clxiong951@sina.cn

Summary

The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30 mcg.

Clinical Details

Official title: A Multicenter, Randomized, Open-labe, Controlled Study to Evaluate the Efficacy and Safety of the Combined Levonorgestrel(LNG) 100mcg and Ethinyl Estradiol(EE) 20mcg for Oral Contraception

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment

Secondary outcome:

Menstrual Cycle Control

Weight changes

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy women,aged 20-35 years who wish to use a contraceptive.

- Women without reproductive system infection complications.

- Willingness to not use other forms of hormonal treatment.

- Three regular menstrual cycles before the study(21-35 days per cycle with 3-7 day's

bleeding period, without amenorrhea or irregular bleeding).

- Signed informed consent prior to entry into the trial.

Exclusion Criteria:

- Any contraindication to the use of oral contraceptives.

- Vascular, metabolic, hepatic, renal, oncologic and other diseases.

Locations and Contacts

Chengliang Xiong, Dr, Email: clxiong951@sina.cn

Beijing, Beijing 100039, China; Not yet recruiting

Beijing, Beijing 100730, China; Not yet recruiting

Chongqing, Chongqing 400010, China; Recruiting

Chongqing, Chongqing 400042, China; Recruiting

Guangzhou, Guangdong 510120, China; Recruiting

Shantou, Guangdong 515041, China; Recruiting

Zhongshan, Guangdong 528403, China; Recruiting

Guiyang, Guizhou 550000, China; Recruiting

Guiyang, Guizhou 550002, China; Recruiting

Wuhan, Hubei 430030, China; Recruiting

Changde, Hunan 415003, China; Recruiting

Changsha, Hunan 410013, China; Recruiting

Nanjing, Jiangsu 210009, China; Recruiting

Nanjing, Jiangsu 210036, China; Recruiting

Yangzhou, Jiangsu 225009, China; Recruiting

Shanghai, Shanghai 200021, China; Recruiting

Taiyuan, Shanxi 030013, China; Recruiting

Xi'an, Shanxi 710061, China; Recruiting

Tianjin, Tianjin 300211, China; Recruiting

Wulumuqi, Xinjiang 830054, China; Recruiting

Taizhou, Zhejiang 317000, China; Not yet recruiting

Additional Information

Starting date: February 2012
Last updated: December 19, 2013

Page last updated: August 23, 2015

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