Navigation Links
Recently Published Study Demonstrates Pharmacokinetic Advantages of ENDOMETRIN(R) Over Crinone(R) for Progesterone Supplementation
Date:8/31/2009

PARSIPPANY, N.J., Aug. 31 /PRNewswire/ -- Endometrin(R) (progesterone) Vaginal Inserts, 100 mg showed clear advantages over Crinone* (progesterone gel) for progesterone supplementation, according to the results of a new pharmacokinetic (PK) study. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo and to support early pregnancy.

ENDOMETRIN(R) rapidly reached higher progesterone serum concentrations, produced greater systemic exposure (AUC 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than Crinone. The study results were published online in Fertility & Sterility, July 15, 2009.

"We are extremely pleased to bring the fertility community a progesterone supplement that dissolves, achieves steady state and clears faster than gel while providing convenience and comfort to patients," said Ed Trott, vice president, medical affairs. "The study results support the benefits provided by Endometrin(R)'s unique mechanism of action, or as we like to say, Dissolves. Delivers. Done."

About the Study

The randomized, open-label, parallel design PK study tested three groups of six healthy subjects, randomized to take Endometrin(R) two times a day or three times a day or Crinone 8% gel daily. Testing was done for a single day and for multiple days. On the single day of dosing, mean C(max) was 17.0 ng/mL in the two times a day group, 19.8 ng/mL in the three times a day group, and 6.8 ng/mL in the gel group. The 24-hour systemic exposure AUC (0-24) was 217 ng h/mL in the two times a day insert group, 284 ng h/mL in the three times a day group, and 81ng h/mL in the gel group.

During the multiple days of dosing, ENDOMETRIN(R) treatments reached steady state within the first two days (24-32 hours), much more rapidly than the gel, which had not reached steady state by 5 days. At 5 days, the Endometrin(R) treatments produced sustained progesterone concentrations exceeding 10 ng/mL across 24 hours. The results suggest that ENDOMETRIN((R)) can reach a targeted concentration range in a substantially shorter time than Crinone. Both ENDOMETRIN(R) groups demonstrated a higher C(max)( )than the Crinone group, with greater systemic exposures. Both the vaginal inserts and the gel were generally safe and well tolerated, and all adverse events were mild.

About ENDOMETRIN

ENDOMETRIN(R) administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

Important Safety Information

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN(R). In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2 percent included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2 percent. ENDOMETRIN(R)( )is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN(R)( ) is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN(R)( ); a known missed abortion or ectopic pregnancy; liver disease; known or suspected breast cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets MENOPUR(R) (menotropins for injection, USP), BRAVELLE(R) (urofollitropin for injection, purified), REPRONEX(R)( )(menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN(R) (progesterone) Vaginal Insert 100 mg in the U.S. to infertility specialists and their patients. Ferring also offers the Q-CAP((TM)), the first and only needle-free reconstitution device, for use with its fertility treatments.

Ferring's line of urology products includes FIRMAGON(R)( )(degarelix for injection) and PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate). Ferring's orthopaedic product includes EUFLEXXA((TM)) (1% sodium hyaluronic acid). Other products include ACTHREL(R) (corticorelin ovine triflutate for injection) and DESMOPRESSIN.

The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology, infertility and orthopaedics. For more information, call 888-337-7464 or visit www.ferringusa.com or www.ferringfertility.com.

*Crinone is a registered trademark of Columbia Laboratories.

Please visit www.ferringfertility.com for Full Prescribing Information for ENDOMETRIN(R).


'/>"/>
SOURCE Ferring Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Noted Vertebroplasty Expert Cites Concerns About Recently Published Study
2. Recently Released Data from the National Survey of Childrens Health Reports That Autism Now Affects 1% of Children and is More Common Than Childrens Cancer, Diabetes, and AIDS Combined.
3. The Hispanic Got Milk? Campaign Recently Visited Atlanta Promoting the Drink Well. Live Well. Tour!
4. New Approach to Progesterone Supplementation in ART Revealed in Recently Published White Paper
5. Clinipace Recently Awarded $2.8 Million to Manage Three New Clinical Projects
6. Recently Reported Childhood Deaths from Influenza Are a Stark Reminder to Vaccinate Now
7. FamilyLife Offers Economic Relief and Hope for Baltimore Marriages by Inviting Recently Unemployed Couples to Attend Marriage Conference for Free
8. Shengtai Pharmaceutical, Inc. Comments on Chinas Recently Approved Health Care Reform Plan
9. 1.2 Million Dollars Recently Awarded to Institute for Myeloma and Bone Cancer Research
10. Benefits of a Lifeclinic LC300 Automated Blood Pressure Monitor Recently Featured on Daytime Medical Talk Show
11. HealthInsuranceFinders.com Publishes Health Insurance Guide for the Recently Unemployed
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... ... jointly issued a letter to withdraw previous guidance issued by the ... identity. The guidance issued in May 2016 by the Obama Administration came in ...
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased ... KLS is a longtime supporter of the event. , "We are pleased that KLS ... Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track record of ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... approved content provider for the National Institute for Health and Care Excellence ... care-related organizations in the National Health Service (NHS) to search, order and purchase ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... in clinical trials, today announced that Premier Research, a leading clinical development service ... Clinical trials are becoming increasingly complex, due in part to an array of ...
(Date:2/23/2017)... ... (PRWEB) February 23, 2017 -- ... to come together to combine its favorite springtime pastime – ... fruit – apples! To celebrate National Nutrition Month, the U.S. ... Madness” bracket tournament – a five-week, five-round online competition spotlighting ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... , Feb. 23, 2017  As National Nutrition ... addition, the Company is helping people live healthier ... customized prescription savings programs in all 50 states ... Assistance Program  and  California Prescription Assistance Program . ... Columbia University for nutritious eating habits: ...
(Date:2/23/2017)... MARIETTA, Ga., Feb. 23, 2017  MiMedx Group, Inc. ... amniotic tissue and patent-protected processes to develop and market ... Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of ... quarter and full year ended December 31, 2016. ... Revenue is a 31% increase over full year ...
(Date:2/23/2017)... Korea , Feb. 23, 2017 LG Innotek today ... LED for sterilization applications. As its sterilization performance is 1.5 times ... the short wavelength ultraviolet rays in the range of 200 -- 280nm, ... proliferation of bacteria by destroying their DNA. LG Innotek,s product emits ... ...
Breaking Medicine Technology: