Assessing Ovarian Function During Prolonged Implant Use

Completed

• Conditions: Contraception

• Registration Number: NCT03058978
• Lead Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Study Start: 2017-03-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovulatory function by body mass index, (kg/m^2)	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 Outcome Measures

Name	Time	Method
Measure number of bleeding days while using the implant during the 30 day study period	30 day period	Participant self-report, daily bleeding diary

Trial Locations

Locations (2)

Washington University in St Louis; 🇺🇸 Saint Louis, Missouri, United States

Planned Parenthood of the St. Louis Region and Southwest Missouri; 🇺🇸 Saint Louis, Missouri, United States