Assessing Ovarian Function During Prolonged Implant Use
1 other identifier
observational
117
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJuly 12, 2022
July 1, 2022
4.8 years
February 10, 2017
July 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ovulatory function by body mass index, (kg/m^2)
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.
30 day period
Secondary Outcomes (1)
Measure number of bleeding days while using the implant during the 30 day study period
30 day period
Interventions
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.
Eligibility Criteria
ENG implants users who are at expiration or beyond the end of the FDA-approved duration of use of the etonogestrel-releasing subdermal implant (ENG implant =3 years)
You may qualify if:
- Enrolled in the prospective EPIC Prolonged Use Study
- 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.
You may not qualify if:
- Have history of female sterilization procedure
- Desire for conception in the next 12 months
- Had their ENG implant removed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, 63108, United States
Washington University in St Louis
St Louis, Missouri, 63110, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen McNicholas, DO, MSCI
Planned Parenthood of the St. Louis Region and Southwest Missouri
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 23, 2017
Study Start
March 1, 2017
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
July 12, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share