Clinical trials: Contraception
Contraception
Integrating Family Planning With Immunization to Improve Maternal and Child Health
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services.
- Trial name
- NCT02447913
- Testing
- Voucher
- Where
- Pakistan
- Volunteers
- 28,000 people
- Sponsor
- Greenstar Social Maketing
Contraception
Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America
The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational…
- Trial name
- NCT01331655
- Testing
- EE20/DRSP (BAY86-5300), EE20/DRSP/L-5-MTHF (BAY98-7071), EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bayer
Contraception
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.
- Trial name
- NCT01490190
- Testing
- Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Contraception
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol.
- Trial name
- NCT01699022
- Testing
- Injection Cyclofem
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries Limited
Contraception
To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives
Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment.
- Trial name
- DOC (NCT01198444)
- Testing
- EE/DRSP (Yasmin Product Family)
- Where
- Poland
- Volunteers
- 11,884 people
- Sponsor
- Bayer
Contraception, Contraception, Postcoital
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods.
- Trial name
- LEVEQ-1 (NCT01096485)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028/Opxion), Levonorgestrel (Postday)
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Pregnancy, Contraception
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.
- Trial name
- NCT02817464
- Testing
- TV-46046 - 400 mg/mL, TV-46046 - 200 mg/mL
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Contraception
Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
Prospective, controlled study. Administration of a specifically formulated supplement to women prescribed oral contraceptives. Evaluation of: a) reduction of adverse effects of the treatment; b) improvement of patients' quality…
- Trial name
- NCT07071389
- Testing
- Zyxelle, Oral contraceptive
- Where
- Italy
- Volunteers
- healthy volunteers welcome
- Sponsor
- Lo.Li.Pharma s.r.l
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles
- Trial name
- NCT05139121
- Testing
- MR-100A-01
- Where
- 100 sites in United States, Canada and 1 more
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- Mylan Technologies Inc.
Contraception
Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
- Trial name
- NCT01797809
- Testing
- EV/DNG (Qlaira, BAY86-5027)
- Where
- South Korea
- Volunteers
- 757 people
- Sponsor
- Bayer
Contraception
Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.
- Trial name
- NCT02403401
- Testing
- Levonorgestrel (BAY98-7196)
- Where
- 100 sites in United States, Japan
- Volunteers
- 1,471 people
- Sponsor
- Bayer
Contraception
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia 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
- NCT02817828
- Testing
- 15 mg E4/3 mg DRSP
- Where
- Belgium
- Volunteers
- 1,577 people, healthy volunteers welcome
- Sponsor
- Estetra
Healthy
A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)
The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2
- Trial name
- NCT00711607
- Testing
- nomegestrol acetate and estradiol
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Contraception
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)
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…
- Trial name
- NCT01253187
- Testing
- EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300), EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca), L-5-MTHF 0.451mg (Metafolin)
- Where
- Netherlands
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
- Trial name
- NCT03700658
- Testing
- TV-46046, Depo-subQ 104
- Where
- Dominican Republic
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Contraception
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)
This study will investigate the efficacy and safety of the monophasic combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in healthy fertile Indian women.
- Trial name
- NCT01723579
- Testing
- Nomegestrol acetate (NOMAC), Estradiol (E2)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Organon and Co
Contraception
Mirena Extension Trial
The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding…
- Trial name
- MET (NCT02985541)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- 49 sites in United States
- Volunteers
- 364 people
- Sponsor
- Bayer
Contraception
Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
- Trial name
- BLOC (NCT03067272)
- Testing
- FemBloc® Permanent Contraceptive System
- Where
- 5 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Femasys Inc.
Contraception, Menorrhagia
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
- Trial name
- ESS-NSPAS (NCT01740687)
- Testing
- ESS305 (Essure, BAY1454032), NovaSure
- Where
- 17 sites in United States
- Volunteers
- 211 people
- Sponsor
- Bayer