Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021097
Recruitment Status : Unknown
Verified December 2013 by Regenex Pharmaceutical, China.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Regenex Pharmaceutical, China

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date December 27, 2013
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • Menstrual Cycle Control [ Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days) ]
    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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oral Contraceptive
Intervention  ICMJE
  • Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
    Tablet, orally, opd
  • Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
    Tablet, orally, opd
Study Arms  ICMJE
  • Experimental: LNG100 mcg/EE20 mcg
    Intervention: Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
  • Active Comparator: LNG 150mcg/ EE 30mcg
    Intervention: Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
1008
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021097
Other Study ID Numbers  ICMJE RH-ZQ-03RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regenex Pharmaceutical, China
Study Sponsor  ICMJE Regenex Pharmaceutical, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chengliang Xiong, Dr Family Planning Research Institute of TJMC,HUST
PRS Account Regenex Pharmaceutical, China
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP