Clinical Trials Logo

Clinical Trial Summary

In this study, researchers want to find out more about how the Etonogestrel (ENG) contraceptive implant device (also known as Nexplanon) changes people's periods. Study subjects will self select into an exposure group- starting combined hormonal contraceptive pills (COC) on the same day as Nexplanon placement or a "delayed initiation" of COC when/if bleeding concerns develop. Patients will be followed for 12 months.


Clinical Trial Description

The study will be conducted at University of Arizona. Investigators will recruit people seeking Nexplanon placement and willing to enroll. We aim to enroll 144 patients. Visit 1: All patients ages 14-24 presenting for contraception services will be screened for potential inclusion. A trained research assistant will conduct a brief patient-centered contraceptive counseling session focusing on patient preferences. If interested in participating, the patient will be given a card to present to their clinician. During the visit, patient and provider will discuss further method selection including risks, benefits, and alternatives. The clinician will assess for contraindications per the CDC MEC for use of COC or the implant. Screening for pregnancy, sexually transmitted infections, and cervical cancer screening will follow as clinically indicated. If pregnancy test is negative and clinician can be reasonably certain that patient is not pregnant using the CDC Selected Practice Recommendations, the ENG implant will be placed. After a clinician encounter, the research assistant will consent those interested in participating. Patients will be assigned a unique identification number once they self-select into their exposure group of choice: 1. ENG implant with initiation of concurrent COC use for bleeding control at time of insertion 2. ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop Enrolled patients will complete Demographic Questionnaire and Bleeding Preference Questionnaire. Enrolled patients in exposure group 1 will receive 6 months COC pills (150 mcg levonorgestrel/30 mcg ethinyl estradiol) and condoms for the first week of back-up method. After 6 months, they will be offered a prescription to continue COC pills. Patients in exposure group 2 will be receive handouts describing how to contact the research team should bleeding concerns develop. A telehealth or in-person visit will be arranged with the research clinicians, during which the patient may opt to start COC pills. A 6 month supply will be provided. Follow-Up: Follow-up contact will be weekly for the first 6 months. There will also be 9 and 12 month contact. Each contact will be a brief text-message survey inquiring about bleeding patterns, pill usage and side effects. The ENG implant will be removed upon request at any time during the study. Study participation will be completed after the 12 month follow-up survey. No blood draws will occur during this study. There is little data available on the adverse effects of ENG implant use and combined COC. This is a common clinical practice to combine use for bothersome bleeding and this study will collect long-term data regarding this practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05116371
Study type Observational
Source University of Arizona
Contact Holly Bullock, MD, MPH
Phone 520-626-6591
Email [email protected]
Status Not yet recruiting
Phase
Start date December 1, 2021
Completion date December 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Active, not recruiting NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Recruiting NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT04965116 - Progestin-Only Pill Use and Breastfeeding Study Phase 4
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Recruiting NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A