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Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

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: NCT04074174
Recruitment Status : Completed
First Posted : August 29, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: NNC0174-0833 Drug: Oral contraceptive (OC) tablets Drug: Acetaminophen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential
Actual Study Start Date : September 12, 2019
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NNC0174-0833 treatment-free period; NNC0174-0833 treatment
During the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833.
Drug: NNC0174-0833
NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks

Drug: Oral contraceptive (OC) tablets
1 tablet daily on days 1-8 and days 79-86

Drug: Acetaminophen
Single dose of acetaminophen as part of a standardised meal on day 1 and day 79




Primary Outcome Measures :
  1. AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    h*pg/mL

  2. AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    h*pg/mL


Secondary Outcome Measures :
  1. Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    pg/mL

  2. Cmax,LN,SS, maximum concentration of levonorgestrel at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    pg/mL

  3. tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    h

  4. tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state [ Time Frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose) ]
    h

  5. AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal [ Time Frame: Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose) ]
    h*microg/mL

  6. AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal [ Time Frame: Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose) ]
    h*microg/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

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): NCT04074174


Locations
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Canada, Quebec
Novo Nordisk Investigational Site
Mount-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04074174    
Other Study ID Numbers: NN9838-4517
U1111-1228-4219 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Acetaminophen
Contraceptive Agents
Contraceptives, Oral
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Reproductive Control Agents
Contraceptive Agents, Female