Contraception Clinical Trial
Official title:
On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
NCT number | NCT03354117 |
Other study ID # | 43881 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 15, 2018 |
Est. completion date | May 31, 2019 |
Verified date | June 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility |
Inclusion Criteria: Women, aged 18-38 - English speaking - Able to consent, literate - Access to smart phone throughout study - History of regular menses - Documented baseline cycle with ovulation - Not currently using or needing hormonal contraception - Not currently using or needing regular NSAIDS - Able to commit to frequency of study visits Exclusion Criteria: - Currently or recently (<2months) pregnant - Currently or recent (<2months) breastfeeding - Current or recent (<2months) use of hormonal medication - Regular NSAID use - Known cardiac risk factors (e.g. personal history of obesity, HTN, cardiac disease, diabetes) - BMI > 30, as some studies have shown decreased efficacy of ulipristal in obese women37 - Allergy or previous unacceptable side effects with study medications |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ovulatory disruption | (1) no follicle rupture or (2) follicle rupture that was (a) not preceded within 24-48 hours by an LH peak, (b) preceded by a blunted LH peak (<21IU/L), and/or (c) followed by a luteal phase progesterone peak of <3ng/mL | 8 weeks from start of study, approximately | |
Secondary | luteal hormone levels | luteal hormone levels | 8 weeks from start of study, approximately | |
Secondary | progesterone hormone levels | progesterone hormone levels | 8 weeks from start of study, approximately | |
Secondary | maximum follicle diameter | maximum ovarian follicle diameter | 8 weeks from start of study, approximately |
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