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Contraception clinical trials

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NCT ID: NCT05675644 Not yet recruiting - Contraception Clinical Trials

Drospirenone-only Pill as Emergency Contraception

Start date: February 2023
Phase: Phase 2
Study type: Interventional

Emergency contraception (EC) provides an additional measure to help prevent pregnancy after unprotected intercourse or contraceptive failure. The two currently available oral emergency contraceptive methods, levonorgestrel (LNG) and ulipristal acetate (UPA), have differing availability and effectiveness. Overweight and obesity are strong risk factors for failure of EC containing LNG and UPA for body mass index (BMI) ≥ 26kg/m2 and ≥35kg/m2, respectively, resulting in limited EC options for much of the population. Drospirenone is a unique progestin that effectively inhibits ovulation when taken daily as progestin-only oral contraception and has pharmacokinetic properties that make it a good candidate for a novel effective emergency contraceptive method across BMI categories. The investigators propose a dose-finding, adaptive-design pilot study evaluating if a single dose of drospirenone can inhibit ovulation prior to the luteinizing hormone (LH) surge. The dose-finding study design will be conducted in a well-established 3+3 model with 2 planned study arms stratified by BMI. The investigators hypothesize that a single dose of drospirenone will effectively inhibit ovulation when administered prior to the LH surge. This pilot data will directly support the dose selection for future research further evaluating the efficacy of drospirenone-only EC aimed at ultimately increasing oral EC options, particularly for patients with overweight or obesity.

NCT ID: NCT05644886 Recruiting - Contraception Clinical Trials

Pilot Study on Engaging Family Physicians in Family Planning in Pakistan

FPFP
Start date: November 21, 2022
Phase: N/A
Study type: Interventional

This study aims to generate evidence on the feasibility and effectiveness of engaging for-profit private sector family physicians and pharmacies to include family planning (FP) as a routine service in rural areas of Pakistan. The study will enlist family physicians and pharmacies in rural areas of Islamabad, Pakistan. Physicians will be randomly assigned to intervention and control groups. Those in intervention arm will received training on family planning and technical support for six months during the duration of the study, to evaluate the impact of training and support in expanding family planning coverage and impact.

NCT ID: NCT05610527 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Hormonal Influences on Inflammatory Bowel Diseases

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms, such as abdominal pain, diarrhea, and fatigue have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. In our previous cross-sectional study, 47% of the levonorgestrel intrauterine device users and 19% of combination oral contraceptive users reported improvement in their cyclical IBD symptom. All hormonal methods may plausibly improve symptoms, but prospective, rigorous data evaluating their efficacy for this purpose are lacking. In order to design a future comparative effectiveness trial on the effect of hormonal contraceptive methods on menstrual-related IBD symptoms, we propose this pilot prospective cohort study of 200 females with IBD: 100 naturally cycling and 100 hormonal contraception users. We will gain essential knowledge on IBD-specific influences on contraceptive method selection, willingness to be randomized to methods, the ability of IBD patient reported outcome (PRO) instruments to differentiate between non-menstrual and menstrual-related IBD symptoms, and assess the potential role of inflammatory markers as outcome measures in future trials. We will recruit participants from the University of Utah IBD Center and clinics, other Utah gastroenterology providers, and through social media ads. Total study commitment will be ~12 weeks. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers in a subset of participants which are commonly used for IBD management. Our aims include: (1) To identify preferences and reasons for contraceptive method selection (or non-use) and willingness to participate in a randomized controlled trial, to inform feasibility of a future trial, (2) To obtain estimates of means and standard deviations for the validated Crohn's Disease and Ulcerative Colitis PRO Instruments by menstrual timing in naturally-cycling participants and between bleeding and non-bleeding days in hormonal contraception users, and (3) To assess correlation between inflammatory marker changes (fecal calprotectin & high sensitivity C-reactive protein), menstrual timing or bleeding/non-bleeding days, and IBD PRO responses, in a subset of 30% of Aim 1 participants. This pilot will inform a future trial design to define non-contraceptive benefits of hormonal contraception on cyclical IBD symptoms. This line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.

NCT ID: NCT05587920 Recruiting - Contraception Clinical Trials

Effect of Oestrogen on Musculoskeletal Outcomes

E2
Start date: December 1, 2021
Phase:
Study type: Observational

This cross-sectional comparison and prospective cohort design study will investigate differences in calcium metabolism, biochemical markers of bone and reproductive health, musculoskeletal health, and iron status between women using different hormonal contraceptives (combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS), hormonal contraceptive injection, and eumenorrheic non-hormonal contraceptive users). The same outcomes will also be examined across a menstrual cycle in the eumenorrheic non-hormonal contraceptive users. The study will test the following hypotheses: Hormonal contraceptive use 1. Biochemical markers of bone resorption and formation and ratio of urinary 44Ca:42Ca will be higher in the implant and injection groups compared with IUS (which exerts localised effects) and non-HC users (ovulatory phase), and lower in COCP compared with non-HC users; 2. Oestradiol and progesterone will be lower in hormonal contraceptive users compared with non-HC users during the ovulatory phase; 3. Bone macro- and microstructure, muscle strength, and tissue properties are different in hormonal contraceptive users compared with non-HC users; 4. Calcium and bone metabolism, reproductive hormones and musculoskeletal function are different between the pill phase and non-pill phase of COCP use. Menstrual cycle phase 1. Calcium and bone metabolism are lower during the ovulatory phase compared with menses, mid follicular and mid luteal phases. 2. Muscle strength and tissue properties are different across the menstrual cycle in non-HC users.

NCT ID: NCT05550064 Recruiting - Contraception Clinical Trials

Structured Contraceptive Counseling During Pregnancy

Start date: November 19, 2022
Phase: N/A
Study type: Interventional

Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth. This is a prospective observational intervention study, aiming to evaluate the effects of structured contraceptive counseling during pregnancy on uptake of contraception postpartum and more specifically on long-acting reversible contraceptive methods, and to identify and explore the provider's and patient's experiences of structured contraceptive counseling during pregnancy.

NCT ID: NCT05525533 Recruiting - Hiv Clinical Trials

Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The goal of the study is to operationalize and test the preliminary impact of providing regular customer feedback from adolescent girls and young women (AGYW) to drug shopkeepers on the distribution of contraceptives and HIV self-testing to AGYW over 18 months.

NCT ID: NCT05521646 Recruiting - Contraception Clinical Trials

Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative

IMPROVE-it
Start date: September 5, 2022
Phase: N/A
Study type: Interventional

Immigrant women in Europe has reported lower use of effective contraception, higher risks of multiple births, and unintended pregnancies compared to native-born women. There is no evidence about this from a Swedish context nor about postpartum contraception. The purpose of this project is to promote equity in sexual and reproductive health (SRH) in Sweden by improving the quality of postpartum contraceptive counselling for and with immigrant women. The Swedish Pregnancy Registry (SPR) will be used to determine if there are any differences in birth spacing and associated complications when comparing immigrant and Swedish-born women. Registration of contraceptive methods in the SPR will be introduced. The IMPROVE-it project will increase the understanding of challenges to contraceptive services postpartum, and how to overcome these.

NCT ID: NCT05505435 Recruiting - Contraception Clinical Trials

Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients

Start date: August 1, 2022
Phase: Phase 4
Study type: Interventional

Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.

NCT ID: NCT05461573 Active, not recruiting - Contraception Clinical Trials

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

Start date: August 2, 2022
Phase: Phase 3
Study type: Interventional

This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.

NCT ID: NCT05444582 Recruiting - Contraception Clinical Trials

Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

Start date: November 7, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective clinical research study to test the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception (EC) and same-day start use that will enroll people receiving care at Planned Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test effectiveness (how well it works in the real world) in a larger, heterogenous population in a usual care setting where participants select their method and are not randomly assigned to it. The study population will include people initiating an LNG 52 mg IUD and meet inclusion and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood Federation of America was the first major healthcare organization to change its practice to incorporate the changes we are studying here. As such, all study participants will be offered the opportunity to choose the interventional IUD at the site they visit. The primary outcome is pregnancy status one month after LNG IUD placement by home urine pregnancy test or clinical record review. Participant follow up concludes one month after enrollment. The purpose of this study is to demonstrate reproducibility of earlier findings in a more heterogenous population. As such, IUD placement is not a study procedure but a component of clinical care. The study interventions only involve study participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or same day start.