Clinical trials: Contraceptive Devices
Female Contraception, Contraception
Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
- Conditions
- Female Contraception, Contraception, Therapeutic Equivalency, Pharmacokinetics
- Trial name
- NCT00709189
- Testing
- Norgestimate/Ehinyl Estradiol; Folic acid.
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Cancer
A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors
This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose pharmacokinetic (PK) of an oral contraceptive (OC)…
- Trial name
- NCT02292732
- Testing
- Trametinib 0.5 mg, Trametinib 2 mg, ORTHO-NOVUM® tablet 1/35
- Sponsor
- GlaxoSmithKline
Contraception
Observational Study on Contraception With Essure in France
Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the…
- Trial name
- SUCCES II (NCT02510443)
- Testing
- ESS305 (Essure, BAY1454032)
- Where
- France
- Volunteers
- 2,644 people, healthy volunteers welcome
- Sponsor
- Bayer
Ovulation Inhibition
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
- Trial name
- NCT00805415
- Testing
- EV/DNG (Qlaira, BAY86-5027, SH T00658K), EV/DNG (SH T00658L)
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Bayer
Residual Drug Amount of EE and LNG
A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal System
The objective of this open-label study was to assess residual EE and LNG content on used Twirla® TDSs, packaging, and the skin surface at the application site after 7 full days of wear and the estimate EE and LNG loaded on…
- Trial name
- NCT07739589
- Testing
- Twirla® (Levonorgestrel/Ethinyl Estradiol) Transdermal System
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Insud Pharma
Diabetes Mellitus, Type 2
A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on…
- Trial name
- NCT01458210
- Testing
- Ortho-Cyclen, Dulaglutide
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Drug Interactions
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of…
- Trial name
- NCT03324685
- Testing
- BIIB074, OC (ethinyl estradiol and levonorgestrel)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Contraception
Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
In spite of many advantages of spermicides, there is no contraceptive efficacy study conducted with any spermicide in women aged over 40 years.
- Trial name
- BZK40+ (NCT03102450)
- Testing
- Benzalkonium Chloride Spermicide Cream
- Where
- 15 sites in France, Russia
- Volunteers
- 151 people
- Sponsor
- Laboratoire Innotech International
Contraception
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)
The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain…
- Trial name
- NCT00725413
- Testing
- etonogestrel implant (Implanon)
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Contraception, Female Contraception
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil.
- Trial name
- NCT00236795
- Testing
- norelgestromin + ethinyl estradiol; triphasil.
- Volunteers
- 1,494 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Advanced Malignancies
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B)…
- Trial name
- NCT07340190
- Testing
- pelabresib, repaglinide, midazolam
- Where
- 6 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Contraception Use
Flo Digital Contraceptive Study
The goal of this clinical trial is to learn if the Flo Digital Contraceptive (FDC) app can effectively prevent unintended pregnancy in women aged 18 years and older residing in the United States.
- Trial name
- FDC (NCT07630064)
- Testing
- Flo Digital Contraceptive
- Where
- United States
- Volunteers
- 3,800 people
- Sponsor
- Flo Health Inc.
Contraception
Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
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…
- Trial name
- NCT01257984
- Testing
- BAY86-5300
- Where
- 43 sites in France, Germany and 3 more
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- Bayer
Infection, Human Immunodeficiency Virus, HIV Infections
A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods.
- Trial name
- NCT01195974
- Testing
- YASMIN, GSK2248761
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Contraception
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism.
- Trial name
- NCT00185224
- Testing
- EV/DNG (Qlaira, BAY86-5027, SH T00658K), SH D00264A (Triquilar)
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Subjects
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl…
- Trial name
- NCT03451110
- Testing
- lemborexant, Loestrin, famotidine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Contraception
Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception
Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study
- Trial name
- NCT02446821
- Testing
- VeraCept
- Where
- 12 sites in United States
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Healthy
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood
The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral…
- Trial name
- NCT05613777
- Testing
- Microgynon®, Iclepertin
- Where
- Germany
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Tuberculosis
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on…
- Trial name
- NCT06354257
- Testing
- Microgynon, GSK3036656
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline