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Trial record 55 of 166 for:    ISOTRETINOIN

The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

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ClinicalTrials.gov Identifier: NCT02967055
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

Condition or disease
Contraception

Detailed Description:
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Serum etonogestrel (ENG) level [ Time Frame: Baseline (enrollment) ]
    ENG levels will be measured prior to initiation of isotretinoin therapy.

  2. Serum etonogestrel (ENG) level [ Time Frame: 4 weeks ]
    ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.

  3. Serum etonogestrel (ENG) level [ Time Frame: 9 weeks ]
    ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG contraceptive implant for their primary mechanism of birth control, placed at least four weeks prior to study enrollment, but in place no longer than three years.
Criteria

Inclusion Criteria:

  • Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
  • Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
  • Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
  • Willing to abstain from taking any Vitamin A supplement during the study period
  • Have a Body Mass Index (BMI) >= 18.5

Exclusion Criteria:

  • Currently breastfeeding
  • Known contraindications to isotretinoin
  • Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors

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): NCT02967055


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Society of Family Planning
Investigators
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Principal Investigator: Aaron Lazorwitz, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02967055     History of Changes
Other Study ID Numbers: 16-0614
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Isotretinoin
Contraceptive Agents
Etonogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Dermatologic Agents
Contraceptive Agents, Female