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Contraception clinical trials

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NCT ID: NCT01602770 Completed - Contraception Clinical Trials

Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Start date: February 6, 2015
Phase:
Study type: Observational

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women. The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use. Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation. In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed. Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).

NCT ID: NCT01598662 Terminated - Contraception Clinical Trials

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

IUD
Start date: July 2009
Phase: N/A
Study type: Interventional

This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.

NCT ID: NCT01595022 Completed - Contraception Clinical Trials

FR01 and FR20 IUS (Intrauterine System) Wearing Study

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

NCT ID: NCT01594632 Completed - Contraception Clinical Trials

Safety,Effectiveness and Acceptability of Sino-implant II in DR

Start date: January 2011
Phase: N/A
Study type: Interventional

A study to assess the contraceptive effectiveness of Sino-implant (II).

NCT ID: NCT01594476 Terminated - Contraception Clinical Trials

Early Postpartum Intrauterine Device (IUD) Placement

Start date: March 2012
Phase: Phase 4
Study type: Interventional

Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement

NCT ID: NCT01590563 Completed - Contraception Clinical Trials

A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device

Start date: April 2012
Phase: N/A
Study type: Interventional

Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.

NCT ID: NCT01590537 Completed - Contraception Clinical Trials

Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Mirabel
Start date: September 2011
Phase: N/A
Study type: Observational

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

NCT ID: NCT01520090 Recruiting - Contraception Clinical Trials

Egyptian Women Knowledge and Use of Different Contraceptive Methods

Start date: January 2012
Phase: N/A
Study type: Observational

Starting from Jan 2012 for an interval of 4 months with minimum number of 1200 egyptian women will be asked to complete a questionairre to evaluate their knowledge of different contraceptive methods

NCT ID: NCT01496898 Completed - Contraception Clinical Trials

Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement

Start date: January 2011
Phase: N/A
Study type: Observational

The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement. The specific research objectives of this project include: 1. Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion. 2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion. 3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

NCT ID: NCT01490190 Completed - Contraception Clinical Trials

Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)

Start date: December 26, 2011
Phase: Phase 4
Study type: Interventional

This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.