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Contraception clinical trials

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NCT ID: NCT04669678 Active, not recruiting - HIV Infections Clinical Trials

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

EPIC
Start date: November 17, 2021
Phase: Phase 4
Study type: Interventional

The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally suppressed, 18-45 years old (inclusive), to evaluate any bidirectional drug-drug interactions (DDIs) between doravirine (DOR)-containing ART and hormonal contraceptive methods. This PK study will enroll women in five distinct groups, each with 21 participants (total of 105 participants), and follow them for approximately 18-30 weeks.

NCT ID: NCT04626596 Active, not recruiting - Contraception Clinical Trials

A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)

Start date: November 19, 2020
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.

NCT ID: NCT04291040 Active, not recruiting - Contraception Clinical Trials

Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies

SUSTAIN
Start date: July 9, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.

NCT ID: NCT04291001 Active, not recruiting - Contraception Clinical Trials

Ovarian Function With ENG Implant and UPA Use

Start date: September 4, 2020
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT04273594 Active, not recruiting - Contraception Clinical Trials

FemBloc® Permanent Contraception - Confirmation Feasibility Trial

BLOC
Start date: February 27, 2020
Phase: N/A
Study type: Interventional

The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.

NCT ID: NCT04092530 Active, not recruiting - Contraception Clinical Trials

Linking Inter-professional Newborn and Contraception Care

LINCC
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes and affect nearly one third of women in the U.S. Rates of postpartum (PP) contraception use remain low, particularly among low-income minority women, leading to high rates of short IPI pregnancies. This proposed study aims to address the gap in the current model of PP contraception care, by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care with the goal of improving access to timely PP contraception.

NCT ID: NCT03978598 Active, not recruiting - Contraception Clinical Trials

Breastfeeding Etonogestrel Implant Study

LACTO-Rod
Start date: June 3, 2019
Phase: Phase 4
Study type: Interventional

The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.

NCT ID: NCT03922334 Active, not recruiting - Contraception Clinical Trials

Navigating New Motherhood 2

NNM2
Start date: January 21, 2020
Phase: N/A
Study type: Interventional

The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. The intervention under investigation is a comprehensive postpartum patient navigator program. Women who are randomized to receive patient navigation will be compared to women who are randomized to receive usual care. Navigators will support women through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum. The investigators will additionally conduct focus groups and surveys with clinical providers.

NCT ID: NCT03877757 Active, not recruiting - Contraception Clinical Trials

Family Planning Elevated: Initiative Evaluation

Start date: February 1, 2019
Phase:
Study type: Observational

Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2) demonstrating additional existing service need among low-income individuals who currently fall in the contraceptive coverage gap (101%-250% federal poverty). Family Planning Elevated provides contraceptive grants, education and training, and technical assistance on comprehensive contraceptive care to participating clinics. The purpose of this evaluation is to assess the effect of FPE on clinic-level family planning service delivery among low-income women who fall in the contraceptive coverage gap compared to those receiving services from matched control clinics which did not receive the intervention. To assess these effects, FPE will collect monthly family planning service delivery data from both intervention and control clinics, beginning 12 months prior to the FPE intervention, and following for 12 months after the FPE intervention ends. A difference-in-difference analysis will compare trends and level-changes in family planning services provided to intervention and control groups.

NCT ID: NCT03762382 Active, not recruiting - HIV Clinical Trials

Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring

Start date: December 12, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.