Oral ContraceptivePhase 3NCT02021097

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

A Phase 3 study testing Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg and Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg in people with Oral Contraceptive, run by Regenex Pharmaceutical, China at 21 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Oral Contraceptive
What is being tested?: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg and Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,008 participants
Where: 21 sitesChina
Study dates: Feb 2012to Feb 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Any contraindication to the use of oral contraceptives.
Vascular, metabolic, hepatic, renal, oncologic and other diseases.

Trial locations and contacts

21 sites in 1 country.

Chengliang Xiong, Dr contact

clxiong951@sina.cn

City, postcode or hospital

Sites recruiting now only

21 sites in 1 country

China21 sites, 21 recruiting

Study site
Beijing, Beijing Municipality, 100039
Not yet recruiting
Study site
Beijing, Beijing Municipality, 100730
Not yet recruiting
Study site
Changde, Hunan, 415003
Recruiting
Study site
Changsha, Hunan, 410013
Recruiting
Study site
Chongqing, Chongqing Municipality, 400010
Recruiting
Study site
Chongqing, Chongqing Municipality, 400042
Recruiting
Study site
Guangzhou, Guangdong, 510120
Recruiting
Study site
Guiyang, Guizhou, 550000
Recruiting
Study site
Guiyang, Guizhou, 550002
Recruiting
Study site
Nanjing, Jiangsu, 210009
Recruiting
Study site
Nanjing, Jiangsu, 210036
Recruiting
Study site
Shanghai, Shanghai Municipality, 200021
Recruiting
Study site
Shantou, Guangdong, 515041
Recruiting
Study site
Taiyuan, Shanxi, 030013
Recruiting
Study site
Taizhou, Zhejiang, 317000
Not yet recruiting
Study site
Tianjin, Tianjin Municipality, 300211
Recruiting
Study site
Ürümqi, Xinjiang, 830054
Recruiting
Study site
Wuhan, Hubei, 430030
Recruiting
Study site
Xi’an, Shanxi, 710061
Recruiting
Study site
Yangzhou, Jiangsu, 225009
Recruiting
Study site
Zhongshan, Guangdong, 528403
Recruiting

Other trials in China

About this study

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

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.

Conditions: Oral Contraceptive
Being tested: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg, Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Keywords: Levonorgestrel；, Ethinyl Estradiol；, Oral Contraceptive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcgDrug
Tablet, orally, opd
Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcgDrug
Tablet, orally, opd

Study groups in NCT02021097
Study group	Role	What they receive
LNG100 mcg/EE20 mcg	Experimental	Not described Receives: Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
LNG 150mcg/ EE 30mcg	Active comparator	Not described Receives: Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment
Measured: From fist dose to 13 treatment cycles (1 cycle=28 days)

Secondary outcomes (2)

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.
Measured: From fist dose to 13 treatment cycles (1 cycle=28 days)
Weight changes
Measured: From fist dose to 13 treatment cycles (1 cycle=28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Feb 2016

First posted27 Dec 2013 (estimated)
Study startFeb 2012
Primary completionFeb 2015 (estimated)
Study completionFeb 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oral ContraceptiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,008 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02021097
Sponsor's protocol ID: RH-ZQ-03RCT
Status last verified: Dec 2013
First submitted: 12 Mar 2013
Last updated: 27 Dec 2013
Results posted: No
Data monitoring committee: No

Want to know more?

Chengliang Xiong, Dr

clxiong951@sina.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
Active, not recruitingPhase 1
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Healthy Participants
RecruitingPhase 1
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Advanced Malignancies
RecruitingPhase 1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
Obesity, Overweight
RecruitingPhase 1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
Healthy Volunteers

All Oral Contraceptive trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02021097
Acronym / sponsor ID: RH-ZQ-03RCT
Conditions: Oral Contraceptive
Keywords: Levonorgestrel；, Ethinyl Estradiol；, Oral Contraceptive
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,008 participants (estimated)
Lead sponsor: Regenex Pharmaceutical, ChinaUniversity, hospital or other
Study start: Feb 2012
Primary completion: Feb 2015 (estimated)
Study completion: Feb 2016 (estimated)
First posted: 27 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LNG100 mcg/EE20 mcg	Experimental	Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
LNG 150mcg/ EE 30mcg	Active comparator	Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Who may qualify

Ages: 20 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

Any contraindication to the use of oral contraceptives.
Vascular, metabolic, hepatic, renal, oncologic and other diseases.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcgTablet, orally, opd	Drug	LNG100 mcg/EE20 mcg
Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcgTablet, orally, opd	Drug	LNG 150mcg/ EE 30mcg

Primary outcome

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)

2 secondary outcomes

Menstrual Cycle Control
Time frame: From fist dose to 13 treatment cycles (1 cycle=28 days)
Weight changes
Time frame: From fist dose to 13 treatment cycles (1 cycle=28 days)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.

Related trials for Oral Contraceptive

RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
Active, not recruitingPhase 1
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Healthy Participants
RecruitingPhase 1
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Advanced Malignancies
RecruitingPhase 1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
Obesity, Overweight
RecruitingPhase 1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chengliang Xiong, Dr contact

clxiong951@sina.cn

Chengliang Xiong, Dr principal investigator

Family Planning Research Institute of TJMC,HUST

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chengliang Xiong, Dr (clxiong951@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02021097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.