Clinical trial NCT03058978: Assessing Ovarian Function During Prolonged Implant Use
Official title: Assessing Ovarian Function During Prolonged Implant Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-02-23
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ovulatory function by body mass index, (kg/m^2)
timeFrame: 30 day period
Secondary outcomes:
measure: Measure number of bleeding days while using the implant during the 30 day study period
timeFrame: 30 day period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Planned Parenthood of the St. Louis Region and Southwest Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
Study officials:
affiliation: Planned Parenthood of the St. Louis Region and Southwest Missouri
name: Colleen McNicholas, DO, MSCI
role: PRINCIPAL_INVESTIGATOR
References: