ContraceptionNCT03058978
Assessing Ovarian Function During Prolonged Implant Use
An observational study of Contraception, run by Planned Parenthood of the St. Louis Region and Southwest Missouri at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Etonogestrel Implant
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- Have history of female sterilization procedure
- Desire for conception in the next 12 months
- Had their ENG implant removed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, 63108
Washington University in St Louis
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Etonogestrel Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel ImplantDevice
Also called Subdermal arm 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 day period
Secondary outcomes (1)
Measure number of bleeding days while using the implant during the 30 day study period
Participant self-report, daily bleeding diary
Measured: 30 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of the St. Louis Region and Southwest Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Colleen McNicholas, DO, MSCI, Principal investigator, Planned Parenthood of the St. Louis Region and Southwest Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058978
- Sponsor's protocol ID
- 201612108
- Status last verified
- Jul 2022
- First submitted
- 10 Feb 2017
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Ovarian Function During Prolonged Implant Use
- ClinicalTrials.gov ID
- NCT03058978
- Acronym / sponsor ID
- 201612108
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Planned Parenthood of the St. Louis Region and Southwest MissouriUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Have history of female sterilization procedure
- Desire for conception in the next 12 months
- Had their ENG implant removed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel ImplantAlso: Subdermal arm implantOvarian 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. | Device | – |
Primary outcome
Ovulatory function by body mass index, (kg/m^2)
Time frame: 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.
1 secondary outcome
Measure number of bleeding days while using the implant during the 30 day study period
Time frame: 30 day period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen McNicholas, DO, MSCI principal investigator
Planned Parenthood of the St. Louis Region and Southwest Missouri
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Planned Parenthood of the St. Louis Region and Southwest Missouri at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulatory function by body mass index, (kg/m^2) (time frame: 30 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.