A Phase 3, Single-Blind, Randomized
Study to Compare DR-2011 to a Progesterone
Gel for Luteal Phase Supplementation for In
Vitro Fertilization
Sponsor:
Duramed Research, Inc.
Purpose:
To study the safety and effectiveness of
an experimental progesterone vaginal ring
designed to deliver progesterone to support
the uterine lining following egg retrieval
in IVF cycles. The study was designed to
compare pregnancy rates and hormone levels
among patients who received the vaginal
ring, progesterone in oil (by injection), or
a progesterone vaginal gel.
2008
Protocol:
A Randomized, Masked Patient,
Independent Reviewer, Multi-Center Pilot
Study to Evaluate the Feasibility of
Sepraspray™ Adhesion Barrier in Laparoscopic
Myomectomy
Sponsor:
Genzyme Corporation
Purpose:
To evaluate an investigational spray (Sepraspray™)
that has been developed to prevent the
formation of adhesions following
laparoscopic surgery. This specific
preliminary trial “pilot study” investigated
the use of Sepraspray in patients who
underwent laparoscopic removal of fibroid
tumors of the uterus (leiomyomas).
Adhesions, sometimes called “scar tissue”,
form as part of the natural healing process
that occurs following an injury – such as a
surgery. Although normal healing is
critical, adhesion formation can cause
organs that are usually in close proximity
to each other to actually stick together.
This can prevent these organs – such as
tubes and ovaries – from functioning
normally. This study was designed to test
whether Sepraspray™ can reduce adhesion
formation after laparoscopic fibroid
removal.
2008
Protocol
A Phase II, Multicenter, Randomized,
Assessor-Blinded, Active comparator, dose
finding study to evaluate AS900672-enriched
versus follitropin alfa (Gonal-F) in
stimulating multiple follicular development
in infertile women undergoing Assisted
Reproductive Technology (ART).
Sponsor:
EMD
Serono Inc.
Purpose:
To evaluate the safety and effectiveness
of an investigational drug designed to
stimulate the growth of ovarian follicles as
part of ART procedures such as IVF. In this
study the investigational drug was compared
to an FDA-approved medication GONAL-f®.
2008
Study:
A Phase II, Prospective, Randomized
Double-Blind, Multicenter, Dose Finding,
Comparative Study for the Evaluation of the
Aromatase Inhibitor Anastrazole
(Multiple-Dose) versus Clomiphene Citrate in
Stimulating Follicular Growth and Ovulation
in Infertile Women with Ovulatory
Dysfunction.
Sponsor:
EMD
Serono Inc.
Purpose:
To determine an effective dose of a new
drug, Anastrazole, developed to stimulate
follicular growth and ovulation in infertile
women who do not ovulate normally. The
study assessed 3 different doses of
Anastrazole, and compared the response to
that of patients receiving Clomiphene
Citrate.
2006
Study:
A phase IV, multicenter, randomized,
double-blinded, clinical trial to confirm
the efficacy of the 75 IU dose of Luveris®
vs. placebo when administered with
follitropin alfa for induction of follicular
development and pregnancy in
hypogonadotropic hypogonadal women with
profound LH deficiency, as defined by a
baseline LH level <1.2 IU/L.
Sponsor:
Serono
Inc
Purpose:
To assess the value of giving an LH
product (Luveris) in addition to Gonal F to
patients who have a rare condition in which
they do not make much LH on their own. In
this study, all patients received Gonal F.
Half were randomized to also receive placebo
while the other half received Luveris in
addition to Gonal F. Patients’ outcomes
were then compared, looking at the number
and quality of egg development, as well as
serum estradiol production and pregnancy
rates.
2005
Study:
A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study to Assess the
Efficacy and Safety of Three Dosage
Strengths of Pulsatile GnRH Administered
Intravenously or Subcutaneously (via
Portable Infusion Pump) Compared to Oral
Treatment with Clomiphene Citrate in
Anovulatory or Oligoovulatory Infertile
Females”
Sponsor:
Ferring
Pharmaceuticals, Inc.
Purpose:
To compare the response of patients who
do not ovulate regularly to stimulation with
3 different doses of gonadotropin releasing
hormone (GnRH) or clomiphene citrate (Clomid).
Clomid is the first line standard treatment
for women who do not ovulate regularly.
Like Clomid, GnRH acts directly on the
pituitary gland in order to induce
ovulation. This study was designed to see
if one or more of three different doses of
GnRH would act as well as or better than
clomid.
2005
Study:
A Prospective multi center pilot study
for the evaluation of an oocyte
freezing/thawing method in patients
undergoing ICSI
Sponsor:
Serono, Inc.
Purpose:
To evaluate a new method of freezing and
then thawing eggs (oocytes) in women
undergoing IVF with ICSI. Oocyte freezing
was early in its development at this time,
and many different protocols had been
proposed to try to optimize the survival and
ability of frozen eggs to develop into
healthy babies. This study evaluated one of
the most popular protocols at the time.
2005
Study:
A Prospective, Randomized, Comparative,
Single Center Trial to Compare the Safety
and Efficacy of Gonal-f RFF versus Gonal-f
RFF in combination with Luveris in In-vitro
Fertilization
Sponsor:
Serono, Inc.
Purpose:
To assess the value of giving an LH
product (Luveris) in addition to Gonal F to
patients undergoing IVF. In this study, all
patients received Gonal F. Half were
randomized to also receive Luveris.
Outcomes were then compared, looking at
differences between the two groups in terms
of side effects, the number and quality of
egg development, serum estradiol production,
and pregnancy rates.
2003
Study:
A Pivotal, Double-Blind, Comparative,
Multicenter Study to Determine the Efficacy
and Safety of Adept in the Reduction of
Post-Surgical Adhesions after Laparoscopic
Surgery”
Sponsor:
ML Laboratories
Purpose:
To evaluate an investigational liquid
(Adept™) developed to prevent the formation
of adhesions following laparoscopic
surgery. Adhesions, sometimes called “scar
tissue”, form as part of the natural healing
process that occurs following an injury –
such as a surgery. Although normal healing
is critical, adhesion formation can cause
organs that are usually in close proximity
to each other to actually stick together.
This can prevent these organs – such as
tubes and ovaries – from functioning
normally. This large, study investigated
the use of Adept in patients who underwent
laparoscopic surgery for the removal of
fibroid tumors of the uterus, treatment of
endometriosis, and/or removal of pelvic
adhesions.
2003
Study:
Safety and Efficacy Study of
N,O-carboxymethylchitosan (NOCC) When Used
for Reduction of Postoperative Adhesion
Development in Women Undergoing Laparoscopy.
Sponsor:
Chitogenics, Inc.,
Purpose:
To evaluate the effectiveness of an
investigational product (NOCC) developed to
prevent the formation of adhesions following
laparoscopic surgery.
2003
Study:
Prospective, Randomized Phase 2 Study to
assess the safety and efficacy of
Anastrazole for the induction of ovulation.
Sponsor:
Serono Laboratories
Purpose:
To determine whether a new type of
medication can cause normal ovulation when
given to women who do not ovulate
regularly. This drug belongs to a class of
medications called aromatase inhibitors, and
this study was designed to determine not
only the effectiveness of this medication,
but also to evaluate the type and frequency
of any side effects that it causes.
2002
Study:
Prospective, Randomized Multi-center two
arm double blind study to evaluate the
safety and effectiveness of the Spray-Gel
Adhesion Barrier System compared to good
surgical technique alone in the prevention
or reduction of postoperative adhesion
formation to the ovaries following
laparoscopic gynecologic surgery
Sponsor:
Confluent Surgical Technologies
Purpose:
To evaluate the effectiveness of an
investigational product (Spray-Gel)
developed to prevent the formation of
adhesions following laparoscopic surgery.
In this study, half of the patients received
Spray-Gel at the completion of their
surgical procedure, whereas the other half
underwent a similar surgical procedure but
did not receive any adhesion preventative.
2001
Study:
A Phase II, Randomized, Double-Blind
Study to Evaluate the Safety and Efficacy of
J867 in Patients with Endometriosis
Sponsor:
TAP
Pharmaceuticals
Purpose:
To evaluate the effectiveness of an
investigational product (code named J867)
developed to arrest and/or reverse disease
progression in patients with documented
cases of endometriosis.
1999
Study:
A Prospective, Randomized, Comparative
Multi- Center Trial to Compare the Safety
and Efficacy of Gonal F and Lupron
Administered as Single and Separate
Injections
Sponsor:
Serono Laboratories
Purpose:
To evaluate the effect of combining
Gonal F and Lupron in the same syringe.
Many medications can be altered when mixed
in the same syringe together. The physicians
at TFC believed that this would not be the
case with Gonal F and Lupron and we
therefore designed a study to test this
hypothesis. Our hope was that, if the drugs
could be combined without reducing their
effectiveness or causing any adverse
reactions, we could reduce the number of
injections required of patients undergoing
in vitro fertilization.
1999
Study:
A Phase I/II Placebo-Controlled Study of
the Safety and Efficacy of Recombinant Human
Relaxin in Infertile Subjects Undergoing
Clomiphene Citrate Therapy
Sponsor:
Connetics Corporation
Purpose:
To assess the safety and effectiveness
of an investigational hormone (relaxin) on
improving pregnancy rates in infertile women
who were being treated with clomiphene
citrate. This study was designed to test
previous data that suggested that relaxin
might increase the likelihood of
implantation.
1999
Study:
Assessment of the
Safety and Efficacy of Cryo-Ablative
Reduction of Menstruation
Sponsor:
Ethicon, Inc
Purpose:
To evaluate a new minimally invasive
surgical method of treating excessive
menstrual bleeding through the use of a
novel freezing technology. There are
several types of surgical and non-surgical
treatment designed to reduce menstrual
bleeding. Most involve the use of heat
and/or electrical current to destroy the
uterine lining. This study was designed to
assess the effect of freezing the tissue.
1998
Study:
A Randomized, Controlled, double-Masked,
Multi-Center Pivotal Study to Evaluate ADCON-P
Adhesion Control Barrier Solution in the
Reduction of Adhesions Following Peritoneal
Cavity Surgery.
Sponsor:
Gliatech, Inc.
Purpose:
To
evaluate the effectiveness of an
investigational product (Adcon P) developed
to prevent the formation of adhesions
following pelvic surgery.
1998
Study:
A Phase
III, Multicenter, Double-Blind, Double
Dummy, Randomized, Comparative, Multi-Center
Trial To Assess the Safety and Efficacy of
Recombinant LH with Profasi in Inducing
Final Follicular Maturation and Early
Luteinization in Infertile Women Undergoing
Ovarian Stimulation with Gonal F Prior to
IVF and ET.
Sponsor:
Serono
Laboratories
Purpose:
To
compare the safety and effectiveness of a
new preparation of luteinizing hormone (LH)
with an older formulation of hCG on egg
maturity in patients undergoing in vitro
fertilization. Profasi (urinary hCG) is a
drug developed from human urine using older
technology. Luveris (recombinant LH) is a
drug with a similar action that is made
using newer recombinant DNA technology. This
study was designed to see if the two drugs
were equally effective at inducing egg
maturity in patients undergoing IVF.
1998
Study:
An Open-Label, Randomized Multicenter
Study to Assess the Efficacy and Safety of
Follistim Solution Formulation Compared to a
Freeze-Dried Cake Formulation, for the
Induction of Ovulation in Clomiphene
Resistant Subjects with Chronic Anovulation
Sponsor:
Organon
Laboratories
Purpose:
To
compare the safety and effectiveness of a
new formulation of Follistim with the
standard preparation when given to women
with ovulatory dysfunction who had failed to
respond to clomiphene citrate.
1998
Study:
The Role of an Ultra-Long (3 month)
Course Of Depot Lupron Prior to Controlled
Ovarian Hyperstimulation (COH) Preparation
for in vitro Fertilization/Embryo Transfer
in Endometriosis Patients
Sponsor:
TAP
Pharmaceuticals
Purpose:
To
determine if it is beneficial to treat
patients with extensive endometriosis with
Depot Lupron for 3 months prior to their
undergoing in vitro fertilization.
Following the laparoscopic diagnosis and
treatment of endometriosis, one group went
immediately into IVF treatment while the
other group was treated with Depot Lupron
for 3 months before their IVF cycle.
1998
Study:
Evaluation of the Efficacy of Interceed
Absorbable Adhesion Barrier in Laparoscopic
Treatment of Endometriosis
Sponsor:
Ethicon
Endosurgery
Purpose:
To
evaluate whether a product already approved
by the FDA for the prevention of adhesions
in open gynecologic surgery was effective
when used in laparoscopic surgery. As most
gynecologic surgery was changing from an
open to a minimally invasive surgical
approach around this time, it was important
to determine if this product was effective
when used through the laparoscope.
1996
Study:
Evaluation of the Safety and Application
Techniques of Sepragel Bioresorbable Gel in
Open and Laparoscopic Gynecologic Pelvic
Surgery
Sponsor:
Genzyme
Corporation
Purpose:
To
evaluate the effectiveness of an
investigational product (Sepragel) developed
to prevent the formation of adhesions
following open and/or laparoscopic surgery.
