Trial record 20 of 86 for:    Open Studies | contraception

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Regenex Pharmaceutical, China
Sponsor:
Information provided by (Responsible Party):
Regenex Pharmaceutical, China
ClinicalTrials.gov Identifier:
NCT02021097
First received: March 12, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Oral Contraceptive
Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Regenex Pharmaceutical, China:

Primary Outcome Measures:
  • The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment [ Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menstrual Cycle Control [ Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days) ] [ Designated as safety issue: Yes ]
    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.

  • Weight changes [ Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1008
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG100 mcg/EE20 mcg Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
Tablet, orally, opd
Active Comparator: LNG 150mcg/ EE 30mcg Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Tablet, orally, opd

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021097

Contacts
Contact: Chengliang Xiong, Dr clxiong951@sina.cn

Locations
China, Beijing
Not yet recruiting
Beijing, Beijing, China, 100730
Not yet recruiting
Beijing, Beijing, China, 100039
China, Chongqing
Recruiting
Chongqing, Chongqing, China, 400042
Recruiting
Chongqing, Chongqing, China, 400010
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510120
Recruiting
Shantou, Guangdong, China, 515041
Recruiting
Zhongshan, Guangdong, China, 528403
China, Guizhou
Recruiting
Guiyang, Guizhou, China, 550000
Recruiting
Guiyang, Guizhou, China, 550002
China, Hubei
Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Recruiting
Changde, Hunan, China, 415003
Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210036
Recruiting
Nanjing, Jiangsu, China, 210009
Recruiting
Yangzhou, Jiangsu, China, 225009
China, Shanghai
Recruiting
Shanghai, Shanghai, China, 200021
China, Shanxi
Recruiting
Taiyuan, Shanxi, China, 030013
Recruiting
Xi'an, Shanxi, China, 710061
China, Tianjin
Recruiting
Tianjin, Tianjin, China, 300211
China, Xinjiang
Recruiting
Wulumuqi, Xinjiang, China, 830054
China, Zhejiang
Not yet recruiting
Taizhou, Zhejiang, China, 317000
Sponsors and Collaborators
Regenex Pharmaceutical, China
Investigators
Principal Investigator: Chengliang Xiong, Dr Family Planning Research Institute of TJMC,HUST
  More Information

No publications provided

Responsible Party: Regenex Pharmaceutical, China
ClinicalTrials.gov Identifier: NCT02021097     History of Changes
Other Study ID Numbers: RH-ZQ-03RCT
Study First Received: March 12, 2013
Last Updated: December 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Regenex Pharmaceutical, China:
Levonorgestrel;
Ethinyl Estradiol;
Oral Contraceptive

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on August 28, 2014