Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)
NCT01723579 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2022-02-16
Summary
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.
Conditions
- Contraception
Interventions
- DRUG
-
Nomegestrol acetate (NOMAC)
Oral tablet with daily release of 2.5 mg
- DRUG
-
Estradiol (E2)
Daily release of 1.5 mg
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
More Related Trials
-
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
NCT00511433 ·Status: COMPLETED ·Phase: PHASE3
-
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)
NCT00711607 ·Status: COMPLETED ·Phase: PHASE1
-
Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol
NCT01361958 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
NCT00511199 ·Status: COMPLETED ·Phase: PHASE3
-
Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
NCT00511342 ·Status: COMPLETED ·Phase: PHASE3
-
A New Treatment Option for Heavy Menstrual Bleeding
NCT01715025 ·Status: UNKNOWN ·Phase: PHASE4
-
Study of Combined Oral Contraceptive Effects in Female Subjects
NCT02157467 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
NCT01670656 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
NCT00212277 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
NCT00212342 ·Status: COMPLETED ·Phase: PHASE3
-
Thorough QT/QTc Study of Multiple Oral Doses of NOMAC-E2 (Org 10486 0 + Org 2317) in Healthy Women (Study 292011)(P05802)
NCT00779532 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
NCT00746096 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
NCT02175394 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
NCT00307632 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Efficacy and Safety With the Transdermal Contraceptive System.
NCT00236769 ·Status: COMPLETED ·Phase: PHASE3
-
Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
NCT00709644 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00391807 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
NCT01709318 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00477633 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
NCT01040845 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product
NCT04193852 ·Status: COMPLETED ·Phase: PHASE1
-
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
NCT02792517 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
NCT02668783 ·Status: TERMINATED ·Phase: PHASE3
-
Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
NCT00709189 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)
NCT02616146 ·Status: TERMINATED ·Phase: PHASE3