A Pilot Prospective, Randomized Pharmacodynamic Study With Assessment of Ulipristal Acetate on Ovarian Activity Following Quickstart of the Etonogestrel Contraceptive Implant
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Ovulation With Implant-alone
研究概览
简要总结
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.
详细描述
Primary Objectives:
- 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.
- 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.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ENG Implant alone
Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
干预措施: ENG implant (Device)
ENG Implant plus oral UPA
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.
干预措施: ENG implant (Device)
ENG Implant plus oral UPA
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.
干预措施: oral ulipristal acetate (Drug)
结局指标
主要结局
Number of Participants With Ovulation With Implant-alone
时间窗: 5 days
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
Number of Participants With Ovulation With Implant and Same Day UPA
时间窗: 5 days
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
次要结局
未报告次要终点
