Assessing Ovarian Function During Prolonged Implant Use

Contraception Clinical Trial

Official title:

Assessing Ovarian Function During Prolonged Implant Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058978
• Other study ID #: 201612108
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2022
• Source: Planned Parenthood of the St. Louis Region and Southwest Missouri
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Etonogestrel 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.

Locations

Country	Name	City	State
United States	Planned Parenthood of the St. Louis Region and Southwest Missouri	Saint Louis	Missouri
United States	Washington University in St Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood of the St. Louis Region and Southwest Missouri	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measure number of bleeding days while using the implant during the 30 day study period	Participant self-report, daily bleeding diary	30 day period