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Contraception clinical trials

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NCT ID: NCT04731818 Completed - Contraception Clinical Trials

An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film

Start date: January 27, 2021
Phase: Early Phase 1
Study type: Interventional

This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.

NCT ID: NCT04717596 Completed - Contraception Clinical Trials

Implementation and Examination of Contraception Care for Hospitalized Adolescents With Mental Health Disorders

Start date: April 7, 2021
Phase:
Study type: Observational

This study is a hybrid trial that examines both the clinical effectiveness and the implementation of BC4Teens Contraception Care. The investigators use a naturalistic one-group longitudinal study design to maximize feasibility and external validity, which is important for understanding implementation and effectiveness in real-world service delivery settings.

NCT ID: NCT04682353 Completed - Contraception Clinical Trials

A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

Start date: December 14, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The total duration of the study for each participant is expected to be up to 19.5 months.

NCT ID: NCT04622306 Completed - Contraception Clinical Trials

Evaluation of Polyurethane Male Condoms

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

NCT ID: NCT04568980 Completed - Cystic Fibrosis Clinical Trials

Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

CASE4CF
Start date: September 30, 2020
Phase:
Study type: Observational

The long-term goal is to study the safety and effectiveness of hormonal contraception for women with cystic fibrosis (CF) and contribute to national guidelines that the Cystic Fibrosis Foundation and the Centers for Disease Control and Prevention (CDC) provide to clinicians. The study objectives are to determine whether hormonal contraceptive methods improve overall pulmonary health, worsen CF-related disease or CF liver disease, or are effective against unwanted pregnancy with concomitant CF transmembrane conductance regulator (CFTR) modulator use. The hypothesis is that hormonal contraceptive methods are safe and do not worsen CF-related complications over time,improve FEV-1 when compared to non-hormonal users, and oral birth control methods with CFTR modulator use.

NCT ID: NCT04523454 Completed - Clinical trials for Diabetes Mellitus, Type 1

Contraception and Pregnancy in Diabetes Mellitus

CAPRE-DM
Start date: October 2, 2020
Phase:
Study type: Observational

This study seeks to expand upon and update this body of work. It will explore the knowledge and understanding women with diabetes have around pregnancy and conception, as well as establish how well prepared these women are for a pregnancy. Using this data, we will develop better services to inform women with diabetes about the contraception and pregnancy, as well inform the development of pre-conception counselling services for women with diabetes. If successful, we would anticipate seeing an improvement in performance in future National Diabetes in Pregnancy audits.

NCT ID: NCT04463693 Completed - Contraception Clinical Trials

Shoulder Contraceptive Implant Study

Start date: October 14, 2020
Phase: Phase 4
Study type: Interventional

This study will be the first to establish pharmacokinetic curves for the etonogestrel contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic data, the investigators can compare this data to already published pharmacokinetic data with conventional implant insertion. This comparison can provide some reassurance that the absorption and distribution of etonogestrel from the contraceptive implant with scapular insertion is similar to that found with conventional insertion. With similar pharmacokinetic properties, the investigators would expect scapular insertion of the implant to maintain similar contraceptive efficacy for the populations of women that may benefit from this alternative insertion site. Preliminary safety data will also enrich the understanding of any potential insertion site side effects with subdermal scapular implant insertion, as the investigators currently only have a single case report with side effect outcomes. The investigators can then use this pilot data to support future larger investigations on subdermal scapular implant insertion given its complete avoidance of the neurovascular complications associated with arm insertion.

NCT ID: NCT04463680 Completed - Tuberculosis Clinical Trials

Rifampin and the Contraceptive Implant

Start date: September 23, 2020
Phase: Phase 4
Study type: Interventional

It is important for women taking rifampin to be aware if they are at greater risk of an unintended pregnancy while on the implant. An unintended pregnancy has many social, emotional, and financial impacts on women and society. Rifampin is also a Class C medication for pregnancy and could have potential negative effects on a developing fetus. Additionally, women considering rifampin for treatment of LTBI face additional risks with an unintended pregnancy, making the reliability of contraception even more important for these women. The results of this study can directly inform counseling on a national and international basis for women who use the contraceptive implant and are considering their treatment options for LTBI.

NCT ID: NCT04425577 Completed - Contraception Clinical Trials

Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length

Start date: January 6, 2020
Phase: N/A
Study type: Interventional

To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is validated as a tool for measuring uterine cavity length, it can be used to guide physicians and subsequently patients in IUD insertion planning.

NCT ID: NCT04423068 Completed - Pregnancy Clinical Trials

Inpatient Adolescent Contraception

Start date: December 10, 2020
Phase: Early Phase 1
Study type: Interventional

The overall goal of this study is to refine and pilot test the investigators novel intervention to offer contraception counseling and initiation for hospitalized female adolescents, focusing on long acting reversible contraception (LARC).