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Contraception clinical trials

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NCT ID: NCT01258660 Completed - Contraception Clinical Trials

Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate

Start date: December 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.

NCT ID: NCT01257984 Completed - Contraception Clinical Trials

Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

NCT ID: NCT01254292 Completed - Contraception Clinical Trials

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Start date: January 6, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study. Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.

NCT ID: NCT01253187 Completed - Contraception Clinical Trials

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)

Start date: October 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception

NCT ID: NCT01253174 Completed - Contraception Clinical Trials

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not using hormonal contraception.

NCT ID: NCT01236768 Completed - Contraception Clinical Trials

Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

ATI-CL13
Start date: October 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

NCT ID: NCT01223521 Completed - Contraception Clinical Trials

Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.

Start date: September 2010
Phase: N/A
Study type: Interventional

A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.

NCT ID: NCT01223313 Completed - Contraception Clinical Trials

A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom

Start date: January 2011
Phase: Phase 3
Study type: Interventional

WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost. WHY IS THIS STUDY BEING DONE? The purpose of this study is to find out: - How well the female condom works to prevent pregnancy - How well the female condom works to prevent transmission of sexually transmitted diseases - How safe the female condom is to use - If urinary tract infections and symptomatic vaginal infections occur while using the female condom - How well women like the female condom - How well the female condom performs. WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation. HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.

NCT ID: NCT01221831 Completed - Contraception Clinical Trials

Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

FIESTA
Start date: September 2010
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age. Primary objective: - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest Secondary objectives: - To investigate ovulation inhibition - To investigate the effect on SHBG - To assess pregnancy rate - To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight - To investigate return of menstruation after treatment - To evaluate general safety and acceptability

NCT ID: NCT01204190 Completed - Contraception Clinical Trials

Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals. With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.