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OpenTrials
Completed

NCT Number: NCT03058978

Assessing Ovarian Function During Prolonged Implant Use

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood of the St. Louis Region and Southwest Missouri, St Louis, Missouri, United States

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About this study

This prospective cohort will evaluate the ovarian function of 210 ENG users during the three years beyond the FDA approved duration. Participants enrolled in the current study, EPIC (Evaluating the Prolonged Use of IUD and Implant for Contraception, NCT02267616), will be contacted via telephone, screened and scheduled to enroll in person. After the signed consent is obtained participants will be asked to complete a brief questionnaire on demographic information and bleeding patterns. Participants will undergo a blood draw to assess serum etonogestrel and serum progesterone levels.

Follow up visits will include a weekly blood draw for three weeks to assess serum progesterone levels. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.

The investigators will enroll participants at seven time points; at method expiration (3 years of use), and in six-month intervals through six years of use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the prospective EPIC Prolonged Use Study
  • 18-45 years of age
  • At expiration or beyond the end of the FDA-approved duration of use of the etonogestrel-releasing subdermal implant (ENG implant =3 years)
  • Ability to consent in English
  • Willing and able to complete required follow-up for the study.

Exclusion criteria

  • Have history of female sterilization procedure
  • Desire for conception in the next 12 months
  • Had their ENG implant removed

Treatment and study plan

Etonogestrel Implant

Device

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.

Other names: Subdermal arm implant

Primary outcomes

  1. Ovulatory function by body mass index, (kg/m^2)

    Time frame: 30 day period

    Comparisons of serum progesterone levels between BMI (kg/m^2) categories will be made using ANOVA or Kruskal-WIllis depending on the normality of distribution.

Secondary outcomes

  1. Measure number of bleeding days while using the implant during the 30 day study period

    Time frame: 30 day period

    Participant self-report, daily bleeding diary

Sponsors and collaborators

Lead sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2017
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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