Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

• ClinicalTrials.gov Identifier: NCT02021097
• Recruitment Status: Unknown
• First Posted: December 27, 2013
• Last Update Posted: December 27, 2013
• Sponsor: Regenex Pharmaceutical, China
• Information provided by (Responsible Party): Regenex Pharmaceutical, China

Tracking Information

• First Submitted Date: March 12, 2013
• First Posted Date: December 27, 2013
• Last Update Posted Date: December 27, 2013
• Study Start Date: February 2012
• Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Oral Contraceptive

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 19, 2013): 1008
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2016
• Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02021097
• Other Study ID Numbers: RH-ZQ-03RCT
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Regenex Pharmaceutical, China
• Study Sponsor: Regenex Pharmaceutical, China
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chengliang Xiong, Dr; Family Planning Research Institute of TJMC,HUST

• PRS Account: Regenex Pharmaceutical, China
• Verification Date: December 2013