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Assessing Ovarian Function During Prolonged Implant Use

NCT03058978 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2022-07-12

No results posted yet for this study

Summary

The study will evaluate how the ovaries may be functioning while using the the Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws. Participants will be followed for 30 days.

Conditions

  • Contraception

Interventions

DEVICE

Etonogestrel Implant

Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws over a 30 day period. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Planned Parenthood of the St. Louis Region and Southwest Missouri

    lead OTHER

Principal Investigators

  • Colleen McNicholas, DO, MSCI · Planned Parenthood of the St. Louis Region and Southwest Missouri

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058978 on ClinicalTrials.gov