Ovarian Function With ENG Implant and UPA Use

NCT04291001 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 129999
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 people capable of pregnancy desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.

Conditions

Contraception

Keywords

emergency contraception; contraceptive implant; ovulation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Ovulation With Implant-alone

  Ovulation will be monitored by ultrasound and serum LH and progesterone levels

  5 days

• Number of Participants With Ovulation With Implant and Same Day UPA

  Ovulation will be monitored by ultrasound and serum LH and progesterone levels

  5 days

Study Arms (2)

ENG Implant alone

ACTIVE COMPARATOR

Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.

Device: ENG implant

ENG Implant plus oral UPA

ACTIVE COMPARATOR

Participants will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.

Device: ENG implant; Drug: oral ulipristal acetate

Interventions

ENG implant DEVICE

This is an FDA-approved contraceptive device

Also known as: Nexplanon

ENG Implant alone; ENG Implant plus oral UPA

oral ulipristal acetate DRUG

This is an FDA-approved oral emergency contraceptive

Also known as: Ella

ENG Implant plus oral UPA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females, age 18-35
• Fluent in English
• BMI \< 30 kg/m2
• No known contraindication to either the ENG contraceptive implant or Ulipristal Acetate (UPA) using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
• Not current pregnant and not at risk of pregnancy (defined as not having penile-vaginal intercourse or using a non-hormonal method of contraception such as a barrier method, condoms, diaphragm, or cervical cap, a copper IUD, or permanent contraception)
• Know the date of last menstrual period
• Have a regular menstrual cycle (24-35 days)
• Be willing to comply with all study requirements
• Be willing to avoid pregnancy for the duration of the study

You may not qualify if:

• Currently pregnancy or breastfeeding
• Use of hormonal contraception or exogenous hormones (estrogen, progestogen, or HCG) in the last month (or past 6 months for depo medroxyprogesterone acetate) or planned use of such during the study
• Vaginal bleeding of unknown etiology
• Allergy to UPA or ENG
• Regular or planned use of glucocorticoids during the study
• Current or planned use of any medication that potentially interacts with UPA or ENG

Sponsors & Collaborators

• University of Utah: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Electronystagmography; ulipristal acetate

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Vestibular Function Tests; Diagnostic Techniques, Otological; Electrodiagnosis

Results Point of Contact

• Title: Lori Gawron, MD
• Organization: University of Utah

lori.gawron@hsc.utah.edu

801-213-4989

Study Officials

• Lori Gawron, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization scheme: block randomization with block size of 4 Blinding protocol: This study will not be blinded as a pilot. The feasibility of the study, including clinic space limitations and provider time, relies on the same healthcare provider for implant insertion and ultrasound in many patients. All statistical analyses will be blinded to the statistician.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: September 4, 2020
• Primary Completion: October 10, 2022
• Study Completion: January 12, 2024
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)