Clinical trials: Contraceptive Devices
Obesity, Bariatric Surgery Candidate
Evaluation of Hormonal Contraceptive Treatments in Obese Women
The aim of our study is to assess the concentrations of different oral contraceptive agents in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve gastrectomy) in order to study the role of the…
- Conditions
- Obesity, Bariatric Surgery Candidate, Oral Contraceptive
- Trial name
- OBECO (NCT02398903)
- Testing
- Blood samples for measurement of drug Css, DXA and impedancemetry
- Where
- 2 sites in France
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Contraception, Unintended Pregnancy
Innovative Model of Patient-Centered ConTraception
This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible…
- Trial name
- IMPACCT (NCT02364037)
- Testing
- CHOICE Project Structured Contraceptive Counseling, Contraceptive Education Session, Cost Support for IUDs and implants
- Where
- 3 sites in United States
- Volunteers
- 1,008 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Body Weight, Contraceptive Usage
Oral Contraceptives and Body Mass Index
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
- Trial name
- NCT01170390
- Testing
- All participants (Aviane), Portia, Aviane
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
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
Contraception
Study of Safety and Efficacy of an Oral Contraceptive
This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy.
- Trial name
- NCT00391807
- Testing
- Norethindrone acetate/ethinyl estradiol
- Where
- 66 sites in United States
- Volunteers
- 1,683 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Contraception
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study
The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in…
- Trial name
- NCT02817841
- Testing
- 15 mg E4/3 mg DRSP
- Where
- 2 sites in United States, Canada
- Volunteers
- 2,148 people, healthy volunteers welcome
- Sponsor
- Estetra
Pharmacokinetics
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at steady state on the steady state pharmacokinetic profile of ethinyl estradiol and norethindrone (Ortho-Novum 1/35).
- Trial name
- NCT01040845
- Testing
- Norethindrone/Ethinyl Estradiol, Colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pregnancy
Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their…
- Trial name
- M-CARES-K (NCT04371900)
- Testing
- Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023), Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)
- Where
- 9 sites in United States
- Volunteers
- 4,700 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Contraception Desired
Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start.
- Trial name
- NCT00369967
- Testing
- NuvaRing
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
Recovery, Oral Contraceptive Use
The Influence of Oral Contraceptive Use on Muscle Recovery
There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed.
- Trial name
- OC-R (NCT04564300)
- Testing
- Training
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Contraception
Transdermal Contraceptive Patch - Endometrial Effects Study
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
- Trial name
- NCT00896571
- Testing
- Ethinylestradiol/Gestogene (BAY86-5016)
- Where
- Germany
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Bayer
Pharmacokinetics, Therapeutic Equivalency
Bioequivalence Study of the Oral Contraceptive (OC) 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 Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
- Conditions
- Pharmacokinetics, Therapeutic Equivalency, Contraceptives, Oral
- Trial name
- NCT00709644
- Testing
- Norgestimate; Ethinyl Estradiol; Folic acid.
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contraception
Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle
We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women.
- Trial name
- NCT00204438
- Testing
- 0.15mg desogestrel /0.03mg ethinyl estradiol
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Saskatchewan
Contraception, Contraceptive Usage
Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.
- Conditions
- Contraception, Contraceptive Usage, Family Planning
- Trial name
- CALM (NCT04725643)
- Testing
- Track bleeding patterns before and after implant
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Early-phase Safety and PK Study of a Vaginal Gel
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and…
- Trial name
- PPCM-01 (NCT07281404)
- Testing
- YASO GEL
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yaso Therapeutics Corporation
Adverse Effect of Oral Contraceptives, Initial Encounter
The Effect of Hormonal Contraception on Female
The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual, metabolic, blood coagulation, hormonal and genetic measures.
- Trial name
- HORMCONTRA (NCT01852786)
- Testing
- Contraceptives, Oral, Combined, Controls
- Where
- Lithuania
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Lithuanian University of Health Sciences