Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 72 of 404 for:    LEVONORGESTREL

A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants

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: NCT03249402
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ethinyl Estradiol + Levonorgestrel Drug: JNJ‑42847922 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : November 24, 2017
Actual Study Completion Date : November 24, 2017


Arm Intervention/treatment
Experimental: Oral Contraceptive Tablet + JNJ‑42847922
All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ‑42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).
Drug: Ethinyl Estradiol + Levonorgestrel
Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.
Other Name: Microgynon 30

Drug: JNJ‑42847922
Participants will receive 40 mg of JNJ‑42847922 once daily on Days 14 to 21 in cycle 2.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) in Cycle 1 [ Time Frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose ]
    The Cmax is the maximum observed plasma concentration.

  2. Maximum Observed Plasma Concentration (Cmax) in Cycle 2 [ Time Frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose ]
    The Cmax is the maximum observed plasma concentration.

  3. Trough Plasma Concentration (Ctrough) in Cycle 1 [ Time Frame: Cycle1: Predose (Day 21) ]
    The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.

  4. Trough Plasma Concentration (Ctrough) in Cycle 2 [ Time Frame: Cycle 2: Predose (Day 21) ]
    The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1 [ Time Frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose ]
    The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

  6. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2 [ Time Frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose ]
    The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 87 Days ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be female of childbearing potential (women with tubal ligation are not accepted)
  • Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m^2) inclusive
  • Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg
  • Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug
  • Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2

Exclusion Criteria:

  • Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
  • Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)
  • Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.
  • Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
  • Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (>) 14 drinks/week for women within 6 months of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249402


Locations
Layout table for location information
Belgium
SGS Life Science Services
Antwerpen, Belgium, 2060
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Layout table for investigator information
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV

Layout table for additonal information
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT03249402     History of Changes
Other Study ID Numbers: CR108351
2016-004725-16 ( EudraCT Number )
42847922MDD1003 ( Other Identifier: Janssen-Cilag International NV )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined