Clinical trials: Levonorgestrel
Contraception
A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)
WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel (LNG) in a time-release form.
- Trial name
- CCN009 (NCT01166412)
- Testing
- levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2, levonorgestrel patch with BMI <32 kg/m2
- Where
- 6 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Premier Research
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
Menorrhagia
Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.
- Trial name
- NCT03642210
- Testing
- Levonorgestrel 52 mg intrauterine system
- Where
- 29 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Medicines360
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
Healthy
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
- Trial name
- NCT01243580
- Testing
- Ortho-Cyclen, AG200-15
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Heavy Menstrual Bleeding, Menorrhagia
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with…
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Uterine Fibroids
- Trial name
- NCT03317795
- Testing
- Levonorgestrel IUS, Tranexamic Acid
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Shannon K. Laughlin-Tommaso
Estimating Rates of Expulsion
Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'.
- Trial name
- NCT01230242
- Testing
- Levonorgestrel Intrauterine Device
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Rebecca Hunt
Healthy
Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.
- Trial name
- ATI-CL21 (NCT01623466)
- Testing
- levonorgestrel
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
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
Pregnancy Prevention
Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
This clinical trial determines if an oral medication taken within 2 days of anticipated ovulation will delay ovulation by 7 days.
- Trial name
- OVULATION (NCT05695352)
- Testing
- Levonorgestrel 1.5mg, Meloxicam 15 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- InnovaGyn, Inc.
Heavy Menstrual Bleeding
Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding
Heavy menstrual bleeding or menorrhagia, is a common problem on women's lives and can burden both patients and health care systems. HMB is defined as cyclic heavy vaginal bleeding.
- Trial name
- NCT03368898
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Pregnancy
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD).
- Trial name
- NCT00669396
- Testing
- Copper T380 IUD, levonorgestrel
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Utah
Contraception
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.
- Trial name
- MINT (NCT00653159)
- Testing
- Levonorgestrel-releasing intrauterine device (LNG-IUS), Copper T380A intrauterine device (CuT380A)
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Infections, Tuberculosis
Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin…
- Trial name
- NCT03819114
- Testing
- Levonorgestrel (LNG)
- Where
- 18 sites in United States, Botswana and 5 more
- Volunteers
- 122 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Contraception
EC PK in Women With Normal and Obese BMI
A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in…
- Trial name
- NCT02689804
- Testing
- LNG-EC, UPA-EC
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Columbia University
Contraception
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
- Trial name
- NCT00551616
- Testing
- CDB-2914, Levonorgestrel
- Where
- 33 sites in United States, Ireland and 1 more
- Volunteers
- 2,221 people
- Sponsor
- HRA Pharma
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer.
- Conditions
- Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7
- Trial name
- NCT00788671
- Testing
- Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System, Quality-of-Life Assessment
- Where
- 7 sites in United States
- Volunteers
- 69 people
- Sponsor
- M.D. Anderson Cancer Center
Complex Atypical Hyperplasia, Endometrial Cancer
Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex…
- Trial name
- NCT02035787
- Testing
- Metformin
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Epithelial Ovarian Cancer
Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce…
- Trial name
- NCT02477202
- Testing
- Mirena® intra-uterine device (IUD)
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Contraception
Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
- Trial name
- NCT00511342
- Testing
- NOMAC-E2, LNG-EE
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Organon and Co