Clinical trials: Contraception
Emergency Contraception
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.
- Trial name
- LIBRella (NCT03208985)
- Testing
- Use Phase (Ulipristal Acetate, 30 mg)
- Where
- 34 sites in United States
- Volunteers
- 1,270 people, healthy volunteers welcome
- Sponsor
- HRA Pharma
Contraception
Mirena Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception.
- Trial name
- NCT01414140
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 567 people
- Sponsor
- Bayer
Contraception
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel…
- Trial name
- NCT00528112
- Testing
- LCS12, LCS16
- Where
- 136 sites in United States, Argentina and 9 more
- Volunteers
- 2,885 people, healthy volunteers welcome
- Sponsor
- Bayer
Emergency Contraception
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.
- Trial name
- ellipseII (NCT01569737)
- Testing
- ella
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- HRA Pharma
Contraception
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
- Trial name
- FINALE (NCT05977751)
- Testing
- FemBloc
- Where
- 12 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Femasys Inc.
Contraception, Liver Metabolism
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
- Conditions
- Contraception, Liver Metabolism, Hemostasis Parameter
- Trial name
- NCT02957630
- Testing
- 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG, 20 mcg EE/3 mg DRSP
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Estetra
Contraception
Study to Investigate Efficacy and Safety of a New Oral Contraceptive
The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.
- Trial name
- NCT00185289
- Testing
- EV/DNG (Qlaira, BAY86-5027, SH T00658K)
- Where
- 50 sites in Austria, Germany and 1 more
- Volunteers
- 1,392 people, healthy volunteers welcome
- Sponsor
- Bayer
Emergency Contraception
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
- Trial name
- NCT01569113
- Testing
- Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
- Where
- 3 sites in Netherlands, Sweden and 1 more
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- HRA Pharma
Contraception, Menopause
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
- Trial name
- NCT02720224
- Testing
- Estetrol
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Estetra
Reproductive Sterilization
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
- Trial name
- EASE (NCT00737061)
- Testing
- Adiana Transcervical Sterilization System
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 770 people, healthy volunteers welcome
- Sponsor
- Hologic, Inc.
Contraception
LCS16 vs. COC User Satisfaction and Tolerability Study
To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
- Trial name
- NCT03074045
- Testing
- Levonorgestrel (Kyleena, BAY86-5028), Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
- Where
- 9 sites in Russia
- Volunteers
- 145 people
- Sponsor
- Bayer
Contraception
Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
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…
- Trial name
- Mirabel (NCT01590537)
- Testing
- Levonorgestrel (Mirena, BAY86-5028), Copper IUD
- Where
- Russia
- Volunteers
- 2,348 people
- Sponsor
- Bayer
Contraception
Evaluation of the Efficacy and Safety of LevoCept
To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study
- Trial name
- NCT02882191
- Testing
- LevoCept
- Where
- 16 sites in United States
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Contraception
Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC.
- Trial name
- NCT00905684
- Testing
- EE30/DRSP (Yasmin, BAY86-5131), Any other OC
- Where
- 13 sites in Albania, Bahrain and 11 more
- Volunteers
- 5,446 people
- Sponsor
- Bayer
Oral Contraceptive
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day…
- Trial name
- NCT00248963
- Testing
- Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Contraception
Study of Bleeding With Extended Administration of an Oral Contraceptive
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
- Trial name
- NCT00338052
- Testing
- Norethindrone 1 mg / ethinyl estradiol 20 mcg
- Where
- 23 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Female Contraception
Bioequivalence Study of Patches With Different Release Profiles
The purpose of this study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
- Trial name
- NCT00697307
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contraception, Female Contraception
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with…
- Trial name
- NCT00261482
- Testing
- norelgestromin + ethinyl estradiol
- Volunteers
- 778 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Contraception
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
- Trial name
- NCT00914693
- Testing
- Ethinylestradiol/Gestodene (BAY86-5016)
- Where
- 66 sites in Argentina, Australia and 6 more
- Volunteers
- 1,694 people
- Sponsor
- Bayer
Contraception
E4/DRSP Single and Multiple Dose PK and Early QT Study
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…
- Trial name
- NCT02874248
- Testing
- 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP, 60 mg E4/12 mg DRSP
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Estetra