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Pregnancy Prevention clinical trials

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NCT ID: NCT06306131 Recruiting - Clinical trials for Pregnancy Prevention

Phase II Study of Ovulation in Obese Women

Start date: December 10, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are: 1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo. 2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments [placebo versus levonorgestrel plus meloxicam]. Participants will: - undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam, - maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding, - collect daily first morning voided urine from menstrual day 9 to 24, - undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14. - allow a blood sample to be drawn on days with ultrasound scans. - Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later. Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs

NCT ID: NCT05952973 Recruiting - Clinical trials for Pregnancy Prevention

The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the impact of SkillTalk among educators, parents, and students. The main question[s] it aims to answer are: - What is the impact of SkillTalk on student sexual-health related outcomes? - What is the impact of SkillTalk on educator microskills? Educator participants will use an online microskills training platform for one week. Parent participants will be asked to use a parent-specific online microskills training platform for one week. Youth participants will not be asked to do anything outside of "business as usual." Researchers will compare the treatment groups to the control groups to measure the impact of SkillTalk.

NCT ID: NCT05950828 Recruiting - Clinical trials for Pregnancy Prevention

Evaluating the Impact of Online Educator Microskill Training on Educator Knowledge and Skill

Start date: August 9, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of SkillTalk, a subscription-based microskills video training library designed to enhance the skills of high school sex educators to implement the frequently used core components of sexual and reproductive health (SRH) curricula. The overall goal of this study is to evaluate the impact of SkillTalk on educators' demonstrable sexual health education skills. Participants will be asked to: - Complete a consent form. - Attend two simulated classroom sessions, either in person or virtually, during which they will teach two prepared lessons that have will be provided to them. - Be video recorded while teaching. - Complete a baseline survey and a post-survey. - If assigned to the treatment group, they will be granted access to SkillTalk for one week to view the videos associated with the answering sensitive questions and using trauma-informed strategies skill sets. Researchers will compare the treatment group to the control group to see if SkillTalk has an impact on educators' demonstrable sexual health education skills.

NCT ID: NCT05695352 Recruiting - Clinical trials for Pregnancy Prevention

Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days

OVULATION
Start date: June 28, 2022
Phase: Phase 2
Study type: Interventional

This clinical trial determines if an oral medication taken within 2 days of anticipated ovulation will delay ovulation by 7 days. The study compares oral placebo tablets (control) to oral levonorgestrel, a synthetic hormone, and meloxicam, a non-steroidal anti-inflammatory drug (treatment) in 21 healthy women between the ages of 18 to 40. The control or treatment are taken 48 hours apart in the first and second menstrual cycle, respectively. The first dose is taken when the ovarian follicle has a diameter of 17 mm measured by transvaginal ultrasound. This follicle diameter is found 2 ± 1.0 days before ovulation. Ovulation is determined by a change in urinary hormone levels analyzed in first morning daily urine. The Investigators anticipate that the control cycle will have an interval to ovulation of ≤ 3 days from first placebo to ovulation while a delay of ≥7 days is found between first treatment to ovulation. A second question is to determine the side effects between control versus treatment based on symptoms such as nausea or abdominal cramping, change in blood pressure or pulse rate and the interval in menstrual bleeding. Each study participant has approximately 9 visits during each of two menstrual cycles. The visits between menstrual day 9 (first visit) to largest follicle are 3 to 6 depending upon follicle growth. A blood sample with a transvaginal ultrasound for ovarian follicle diameter is obtained at each visit. The appropriate medication is taken when the ovarian follicle largest diameter is 17 mm. The second dose is taken 2 days later with interim and final visits at 5 and 10 days following first dose. Each participant collects first morning urine from menstrual day 9 to 23. A teaspoonful of morning urine is placed in a storage tube and kept in a refrigerator freezer section until returned at a scheduled visit. All urine samples are kept frozen until analyzed for the metabolites of estrogen and progesterone by a central research laboratory. A change in the ratio of estrogen to progesterone metabolites is indicative of ovulation because more progesterone is secreted after ovulation from the ovary. The primary research outcome compares the interval in days from first dose of medication to ovulation between control and treatment. Secondary outcomes are menstrual cramps, vaginal bleeding, nausea, and headache, and changes in blood pressure, pulse, and interval between menstrual periods in control compared to treatment cycles.

NCT ID: NCT05360576 Completed - Clinical trials for Pregnancy Prevention

An Open-label, Randomized, 2-Period, Crossover, Pharmacokinetics Study

Start date: February 24, 2022
Phase: Phase 2
Study type: Interventional

An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females

NCT ID: NCT05360550 Completed - Clinical trials for Pregnancy Prevention

A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP- 5415 on Ovarian Function in Healthy Adult Females

Start date: July 5, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the inhibition of ovulation in Cohort #1 (Body Mass Index of ≥ 18 kg/m2 to ≤ 30 kg/m2) after contraceptive vaginal ring LSP-5415 application for 3 treatment cycles.

NCT ID: NCT04809155 Active, not recruiting - Clinical trials for Pregnancy Prevention

Girl2Girl: A Web-based Trial

G2G
Start date: July 7, 2020
Phase: N/A
Study type: Interventional

This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents.

NCT ID: NCT04233632 Completed - Clinical trials for Pregnancy Prevention

Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom

Start date: November 27, 2019
Phase: N/A
Study type: Interventional

This research study aims to assess the effectiveness of three female condoms [Cupid, Cupid 2 and Female Condom 2(FC2)] for the prevention of pregnancy among women choosing the female condom (FC) as their method of fertility regulation. Participants will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage.

NCT ID: NCT04076774 Completed - HIV Prevention Clinical Trials

A Functional Performance Study of The Wondaleaf Female Condom

Start date: March 27, 2019
Phase: N/A
Study type: Interventional

This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Wondaleaf Condom" is a new female condom. Participants will use both condoms. The study aims to determine how well these condoms work comparatively. Study visits include a screening/enrolment visit and 2 follow up visits.

NCT ID: NCT03729726 Recruiting - Clinical trials for Sexually Transmitted Diseases

Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program

Start date: May 11, 2017
Phase: N/A
Study type: Interventional

This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no condoms/contraceptives). FF will implement the 2.0 PREIS Program with three cohorts of African-American youth in the 6th to 8th grades. FF aims to recruit and enroll 400 students who are new to the program for Cohort 1, 150 new students for Cohort 2, and another 150 new students for Cohort 3. These cohorts of eligible students will come from grades 6-8 in Woodland and McNair middle schools and projected to attend Banneker high school. Random assignment will be an ongoing process throughout the project enrollment periods. By the end of the recruitment processes, a total of 700 students will be randomly assigned to either the treatment or the control group, resulting in 350 students in each condition. Each year, the FF 2.0 PREIS intervention model will offer year-round grant-funded services, including after-school, summer programming, and parent engagement activities. The 350 youth randomly assigned to the treatment group will be offered the FF 2.0 PREIS program (Cohort 1 will target 200 treatment youth from January 2018 through June 2018; Cohort 2 will target 75 treatment youth from August 2018 through May 2019; and Cohort 3 will serve 75 treatment youth from August 2019 through May 2020.), while the 350 students assigned to the control group may receive after school and/or summer programming from another community-based organization. The primary hypotheses for the RCT study are the following: significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in vaginal sex than their control group peers do by the time of the end of the program and also at the six-month follow-up; significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in recent unprotected sex significantly than the control group students do at the end of the program and also at the six-month follow-up; and significantly greater numbers of participants in the FF 2.0 PREIS intervention remain abstinent or report condom use during recent vaginal sexual activity than the control group students do at the end of the program and also at the six-month follow-up.