A Pilot Prospective, Randomized Pharmacodynamic Study With Assessment of Ulipristal Acetate on Ovarian Activity Following Quickstart of the Etonogestrel Contraceptive Implant

129999

Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to women 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 women 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.

2020-09-04

2022-10-10

2024-02-01

Active (not recruiting)

Early phase I

40

Inclusion Criteria: * Healthy women, 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Randomization scheme: block randomization with block size of 4\n\nBlinding 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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-11-14