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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNG100 mcg/EE20 mcg | Experimental |
| |
| LNG 150mcg/ EE 30mcg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg | Drug | Tablet, orally, opd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment | From fist dose to 13 treatment cycles (1 cycle=28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual Cycle Control | Menstrual cycle control was evaluated by analyzing cycle characteristics, such as cycle length, the incidences of breakthrough bleeding, spotting, and amenorrhea and the duration and intensity of withdrawal bleeding. During the trial, spotting was defined as a light flow that did not necessitate sanitary protection, whereas bleeding was defined as a heavier flow that was similar to normal menstrual flow and necessitated sanitary protection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengliang Xiong, Dr | Contact | clxiong951@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chengliang Xiong, Dr | Family Planning Research Institute of TJMC,HUST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Not yet recruiting | Beijing | Beijing Municipality | 100039 | China | ||
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| Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg |
| Drug |
Tablet, orally, opd |
|
| From fist dose to 13 treatment cycles (1 cycle=28 days) |
| Weight changes | From fist dose to 13 treatment cycles (1 cycle=28 days) |
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
| Recruiting | Chongqing | Chongqing Municipality | 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 Municipality | 200021 | China |
| Recruiting | Taiyuan | Shanxi | 030013 | China |
| Recruiting | Xi’an | Shanxi | 710061 | China |
| Recruiting | Tianjin | Tianjin Municipality | 300211 | China |
| Recruiting | Ürümqi | Xinjiang | 830054 | China |
| Not yet recruiting | Taizhou | Zhejiang | 317000 | China |
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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