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Contraceptive Usage clinical trials

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NCT ID: NCT03336346 Completed - HIV Infections Clinical Trials

Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana

Start date: November 15, 2017
Phase:
Study type: Observational

The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG) have a 20% or greater change in their ENG plasma levels, compared to women taking no antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking dolutegravir have significantly higher ENG plasma levels than ENG implant users taking efavirenz. This is a cross-sectional, non-randomized evaluation to compare ENG levels between 3 and 12 months post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2) women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This study will be conducted in Botswana in Southern Africa among women using the ENG implant, and involves a one-time collection of blood and questionnaire.

NCT ID: NCT03279120 Completed - Contraceptive Usage Clinical Trials

Safety, PK, and PD Study of IVRs Releasing TFV and LNG

TFV/LNG IVR
Start date: September 28, 2017
Phase: Phase 1
Study type: Interventional

This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.

NCT ID: NCT03253783 Completed - Contraceptive Usage Clinical Trials

The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program

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

This study uses a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter. Users access Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

NCT ID: NCT02729337 Completed - HIV Clinical Trials

Affecting the Epidemiology of HIV in Uganda

Start date: December 6, 2017
Phase: N/A
Study type: Interventional

The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.

NCT ID: NCT02613039 Completed - Clinical trials for Mental Health Wellness 1

Oral Contraceptive Therapy and Sexuality

COSEX
Start date: October 2015
Phase: Phase 4
Study type: Interventional

Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or glucocorticoid actions. However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical anthropometric measurements, including body mass index and waist circumference. In this context, it would be worth to evaluate the effects of combined OCs on metabolic and sexual health (sexual desire, arousal, and other parameters of sexual health), body image and mood.

NCT ID: NCT02411357 Completed - Opioid Dependence Clinical Trials

Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II

Start date: May 5, 2015
Phase: N/A
Study type: Interventional

Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.

NCT ID: NCT02173808 Completed - Contraceptive Usage Clinical Trials

A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception

CCN011
Start date: May 2011
Phase: Phase 1
Study type: Interventional

To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).

NCT ID: NCT01425060 Completed - Opioid Dependence Clinical Trials

Improving Effective Contraceptive Use Among Opioid-maintained Women

Start date: October 2011
Phase: Phase 1
Study type: Interventional

Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to develop and test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women and to examine the impact of more effective contraceptive use on condom use. The proposed research may reduce unintended pregnancy among opioid-dependent women without increasing their risk of sexually transmitted infections and the knowledge gained will also have implications for addressing high rates of unintended pregnancy in the general population.

NCT ID: NCT01392157 Completed - Contraceptive Usage Clinical Trials

Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The main side-effect of Implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main causes of early discontinuations. Unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. Nevertheless, previous studies with other progestin-only contraceptives (including Implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation. The availability of Implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents.

NCT ID: NCT01334190 Completed - Contraceptive Usage Clinical Trials

A Prospective Observational Study of the Performance of Zarin in Kenya

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

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study: - a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and - a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.