Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

2020-01-22 12:12:55 | BioPortfolio


This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.


The primary objective of the study is to investigate the relative bioavailability of Dienogest of 1 tablet formulation with Dienogest 2.0 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

- Test Product: Product manufactured by Laboratorios Andrómaco S.A.

- Reference Product: Visannette [Trademark], product of Bayer AG, Germany. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Dienogest will be determined. Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose.

The washout period between the two study periods will be at least 14 days. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Dienogest in plasma.

The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.

Study Design




Dienogest 2.0 mg Test Drug, Dienogest 2.0 mg Reference Product






Laboratorios Andromaco S.A.

Results (where available)

View Results


Published on BioPortfolio: 2020-01-22T12:12:55-0500

Clinical Trials [1804 Associated Clinical Trials listed on BioPortfolio]

Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product

This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The Pilot study will be performe...

Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest an...

Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 2 With and Without Suppression by Dienogest

This study aims at investigating the fertility outcome of endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in endometriosis pat...

Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam

Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam

Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF

Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the reproductive age group . It is characterized by the presence of endometrial tissue outside the...

PubMed Articles [16775 Associated PubMed Articles listed on BioPortfolio]

Significant risk factors for malignant transformation of ovarian endometrioma during dienogest treatment: a case report and retrospective study.

To determine the prevalence of and risk factors for malignant transformation of ovarian endometrioma during dienogest therapy, which is very rare, we examined multiple cases of malignant transformatio...

Effects of long-term treatment with Dienogest on the quality of life and sexual function of women affected by endometriosis-associated pelvic pain.

The aim of this prospective study was to evaluate quality of life (QoL) and sexual function of women affected by endometriosis pain treated with Dienogest (DNG) for 24 months.

Bioequivalence Study of 2 Formulations of Rivaroxaban, a Narrow-Therapeutic-Index Drug, in Healthy Chinese Subjects Under Fasting and Fed Conditions.

This study aimed to evaluate the bioequivalence (BE) of 2 formulations of the 10-mg rivaroxaban tablet. The study was a randomized, open-label, 4-period, crossover study that included 28 healthy subje...

Recurrence of uterine adenomyosis after administration of gonadotropin-releasing hormone agonist and the efficacy of dienogest.

This study elucidated the degree of adenomyosis recurrence following gonadotropin-releasing hormone agonist (GnRHa) discontinuation and dienogest efficiency for recurrent adenomyosis. This retrospecti...

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of atorvastatin in Chinese subjects

The purpose of this study was to evaluate the bioequivalence of two formulations of atorvastatin using the reference-scaled average bioequivalence (RSABE) method and to study the pharmacokinetics of a...

Medical and Biotech [MESH] Definitions

A performance test based on forced MOTOR ACTIVITY on a rotating rod, usually by a rodent. Parameters include the riding time (seconds) or endurance. Test is used to evaluate balance and coordination of the subjects, particular in experimental animal models for neurological disorders and drug effects.

An in vitro test used in the diagnosis of allergies including drug hypersensitivity. The allergen is added to the patient's white blood cells and the subsequent histamine release is measured.

Removal of a drug from the market due to a problem occurring in the manufacture or distribution of the product.

An immunoenzyme test for the presence of drugs and other substances in urine and blood. The test uses enzyme linked antibodies that react only with the particular drug for which the sample is being tested.

Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

More From BioPortfolio on "Bioavailability of Dienogest 2.0 mg With Regards to Reference Product"

Quick Search

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Searches Linking to this Trial