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Contraception clinical trials

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NCT ID: NCT02957292 Completed - Contraception Clinical Trials

A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).

COLIBRI
Start date: June 1, 2016
Phase: Phase 4
Study type: Interventional

The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age. Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea. In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs. The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users. This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.

NCT ID: NCT02945670 Completed - Contraception Clinical Trials

Using Focus Group to Explore Cultural Acceptability of Contraception

Start date: January 2, 2017
Phase:
Study type: Observational

The purpose of this study is to learn what women of childbearing age think of Long Acting Reversible Contraception. A variety of myths regarding LARCs have been described in the literature. This study is designed to asses women's cultural belief's regarding LARCs. Investigators are looking to collect information from women in general, rather than solely who are seeking contraception. Investigators will be recruiting women ages 18-45 years from seven family health centers affiliated with UPMC. Participants will be asked to a attend a 60-90 minutes focus group session. During the session the facilitator will try to engage participants in a discussion about contraception in general. They will also be asked to complete a short demographic survey of 8-12 questions. Data from focus groups will be assessed for recurring themes which will be used to create a cultural survey instrument that will be used in the second phase of the study.

NCT ID: NCT02922127 Completed - Contraception Clinical Trials

Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation

Start date: December 16, 2016
Phase: Phase 1
Study type: Interventional

Breast cancer accounts for almost a quarter of all cancers in women. In the United States (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer. There is an urgent need to develop acceptable means of preventing breast cancer both for high risk and average risk women. The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation (increase in number of cells in the breast) and to measure its effect compared to that found with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use as daily medication up to 12 months for the treatment of abnormally heavy bleeding at menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its use as a daily contraceptive. The investigators will use breast biopsies to compare breast cell proliferation, comparing biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA and COC). The investigators will also compare the changes in the 2 groups to each other. The comparison of the effect of UPA to that of a conventional COC is because of UPA's potential use as a daily contraceptive. Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of hormones on the breast are rapid and an anti-progestin such as UPA, which will block the action of progesterone in the breast, would be predicted to quickly lower breast cell proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and are reassuring. COC use has not been found to lower breast cell proliferation and is not associated with any decrease in risk of breast cancer. The changes in breast cell proliferation will also be compared to changes seen on breast MRI. If the changes are highly correlated future studies will be able to be done without the need for breast biopsies.

NCT ID: NCT02905526 Completed - Contraception Clinical Trials

An Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 month follow-up.

NCT ID: NCT02905513 Completed - Contraception Clinical Trials

An Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan

Start date: November 16, 2016
Phase: N/A
Study type: Interventional

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.

NCT ID: NCT02905461 Completed - Contraception Clinical Trials

An Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine

Start date: December 8, 2016
Phase: N/A
Study type: Interventional

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.

NCT ID: NCT02904629 Completed - Pregnancy Clinical Trials

Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

TPP
Start date: May 2016
Phase: N/A
Study type: Interventional

The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of "Respecting the Circle of Life: Mind, Body and Spirit" on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.

NCT ID: NCT02882191 Completed - Contraception Clinical Trials

Evaluation of the Efficacy and Safety of LevoCept

Start date: November 2016
Phase: Phase 2
Study type: Interventional

To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study

NCT ID: NCT02874248 Completed - Contraception Clinical Trials

E4/DRSP Single and Multiple Dose PK and Early QT Study

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).

NCT ID: NCT02866279 Completed - Contraception Clinical Trials

Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

Start date: November 2016
Phase: N/A
Study type: Interventional

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period