Assessing Ovarian Function During Prolonged Implant Use
| Status: | Recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 12/2/2018 |
| Start Date: | March 1, 2017 |
| End Date: | December 2019 |
| Contact: | Loire Biggs, BA |
| Email: | loirebiggs@wustl.edu |
| Phone: | 314-747-1425 |
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.
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.
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.
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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Colleen P McNicholas, DO
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