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Contraception clinical trials

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NCT ID: NCT03585712 Completed - Contraception Clinical Trials

Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

Start date: July 24, 2018
Phase: Phase 2
Study type: Interventional

Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill. To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours. This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.

NCT ID: NCT03585361 Completed - Pregnancy Clinical Trials

Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.

NCT ID: NCT03571932 Completed - Contraception Clinical Trials

Assessment of Family Planning and Immunization Service Integration in Liberia

Start date: November 2016
Phase:
Study type: Observational

This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities in Lofa and Grand Bassa counties in Liberia. MCSP used a longitudinal, pair-matched design to monitor the effect of integrating immunization and FP services on utilization of FP and routine immunization services. In Lofa and Grand Bassa counties, 36 facilities were pair-matched to intervention and comparison sites based on predetermined criteria. After approximately 9 months of implementation, MCSP conducted a qualitative study employing key informant interviews (KIIs) and focus group discussions (FGDs) at intervention and comparison sites, and with district-, county-, and national-level MOH supervisors and managers.

NCT ID: NCT03562624 Completed - Contraception Clinical Trials

A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components

INDessa
Start date: June 22, 2018
Phase: Phase 2
Study type: Interventional

This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women. It is designed to investigate the pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND), as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this study, Jaydess, as an LNG-only IUS, will be used as a comparator.

NCT ID: NCT03559634 Completed - Contraception Clinical Trials

Contraception Initiation Feasibility in the Pediatric ED

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

Many female adolescents using the pediatric emergency department (ED) are at higher risk for unintended pregnancy. This is a significant public health issue and hormonal contraception is the mainstay of prevention. Many barriers to hormonal contraception exist and other studies have demonstrated that referral from the ED for hormonal contraception leads to poor follow up. This study will be a pilot study to assess the feasibility of initiating hormonal contraception in the pediatric ED.

NCT ID: NCT03514914 Completed - Contraception Clinical Trials

Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy

CHARM2
Start date: June 7, 2018
Phase: N/A
Study type: Interventional

Globally, 41% of all pregnancies are unintended, increasing risk for maternal and infant morbidity and mortality. Most unintended pregnancies occur in the context of contraceptive non-use or failure. Women with husbands who are not supportive of contraception are more likely to report contraceptive non-use, and women with sexually abusive husbands are more likely to report contraceptive failure. This highlights the need for family planning (FP) interventions that engage both women and men, focus on eliminating marital sexual violence (MSV) and promote use of effective contraceptives including long-acting reversible contraception (LARC). Rural India, with some of the lowest rates of contraception and highest rates of marital violence globally, offers an important context to test such interventions, with global implications. Prior research from this team documents promise of the original CHARM intervention, a gender equity (GE) FP intervention engaging men and delivered by male health providers over 3 months. This intervention improved contraceptive use and reduced likelihood of MSV, but demonstrated no reduction in unintended pregnancy; additionally, it demonstrated high participation from men (91%) but less from couples (51%), largely due to women's discomfort with a male provider. Poor reach to women and provision of only short-acting contraceptives, more vulnerable to contraceptive failure, may have compromised an effect on unintended pregnancy outcomes. Based on these findings, CHARM2 includes CHARM sessions for men AND parallel women-focused GE+FP sessions delivered by a female provider and inclusive of broader contraceptive options, including LARC. This study seeks a) to implement CHARM2, b) to evaluate its impact on contraceptive use, unintended pregnancy, and MSV with rural couples in India, and c) to assess its potential for sustainability in rural India, using implementation science methods. To evaluate the impact of CHARM2, a 2-armed cluster randomized controlled trial will be conducted with up to N=1200 married couples from 20 geographic clusters (n=50-60 couples per cluster) in rural India. Participants will receive CHARM2 or the standard of care, which will involve community health workers offering pills/condoms and linking women to public health clinics. Outcomes will be assessed via pregnancy testing and surveys at baseline, 9 & 18-month follow-ups. Implementation science methods will assess the quality, scalability, and replicability of CHARM2 for uptake by rural health care systems (i.e., sustainability).

NCT ID: NCT03512860 Completed - Contraception Clinical Trials

Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study

Start date: April 12, 2018
Phase: Phase 1
Study type: Interventional

The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)

NCT ID: NCT03505047 Completed - Contraception Clinical Trials

Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

Start date: May 10, 2018
Phase: N/A
Study type: Interventional

The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.

NCT ID: NCT03499379 Completed - Contraception Clinical Trials

Stress Hormones and IUDs

Start date: April 16, 2018
Phase:
Study type: Observational

Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

NCT ID: NCT03493295 Completed - Contraception Clinical Trials

Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern

BERTA
Start date: April 25, 2018
Phase:
Study type: Observational

The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status. Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.