Contraception
Conditions
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.
Interventions
DEVICEEtonogestrel 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
Merck Sharp & Dohme LLC
Planned Parenthood of the St. Louis Region and Southwest Missouri
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Measure number of bleeding days while using the implant during the 30 day study period | 30 day period | Participant self-report, daily bleeding diary |
Countries
United States
Outcome results
None listed