Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Oral Contraceptive Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02021097
• Other study ID #: RH-ZQ-03RCT
• Status: Recruiting
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: December 19, 2013
• Start date: February 2012
• Est. completion date: February 2016

Study information

• Verified date: December 2013
• Source: Regenex Pharmaceutical, China
• Contact: Chengliang Xiong, Dr
• Email: clxiong951[@]sina.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1008
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

Drug:
• Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
Tablet, orally, opd
• Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Tablet, orally, opd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regenex Pharmaceutical, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	From fist dose to 13 treatment cycles (1 cycle=28 days)	Yes
Secondary	Weight changes		From fist dose to 13 treatment cycles (1 cycle=28 days)	Yes