Principal Investigator: Lori Gawron
Keywords: ovulation , implant , EC , UPA Department: Obstetrics And Gynecology (Dept)
IRB Number: 00129999
Specialty: OB/Gyn, General
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Amy Orr
amy.orr@hsc.utah.edu
801-213-2774

Brief Summary

Primary:

  1. To determine point estimates for the incidence of ovulation within five days of oral ulipristal acetate (UPA) administration with same day etonogestrel (ENG) implant insertion in the presence of a dominant follicle.
  2. To determine point estimates for the incidence of ovulation within five days of etonogestrel (ENG) implant insertion alone in the presence of a dominant follicle.

Secondary:

  • Define the timing of ovulation in the 1st seven days following UPA with same day ENG implant insertion in the presence of a dominant follicle.
  • Define the timing of ovulation in the 1st seven days following ENG implant insertion in the presence of a dominant follicle.
  • Assess ovarian quiescence by ultrasound, Luteinizing hormone (LH) and progesterone measurements 14 days (+/- 2 days) after implant initiation.

Clinical Hypotheses

  • Combined oral UPA administration with same day ENG implant insertion will interfere with UPA’s effect in delaying ovulation as occurs with oral progestogens given within 1-2 days of UPA.
  • The ENG implant alone delays ovulation beyond 5 days when initiated at the time of a dominant follicle.

Inclusion Criteria

Healthy women, age 18-35 years

Fluent in English and/or Spanish

BMI < 30 kg/m2,

No known contraindication to either the ENG contraceptive implant or UPA using the CDC Medical Eligibility Criteria for Contraceptive Use 2016,

Not currently 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 their last menstrual period

Have a regular menstrual cycle (24-35 days)

Be willing to comply with the study requirements

Be willing to avoid pregnancy for study duration

Exclusion Criteria

Current 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 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