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CompletedNCT01081626Updated Feb 13, 2014Results posted

Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction

A Phase 4 interventional study of Recombinant FSH (follitropin alpha) in Ovulation Induction, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 3 sites in 3 countries. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2014-02-13.

Sponsored by Merck KGaA, Darmstadt, Germany · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
18 Years to 37 Years
Sex
Female
01

Study summary

This is an open-label, prospective, randomized, controlled, multicentric, multinational, phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with chronic anovulation. It has been observed that conventional high dose set up regimen of gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in terms of overall pregnancy rates. However, development of multiple follicles leading to multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) is the major complications associated with this high dose set up. Chronic low-dose (CLD) protocols of follicle stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary to promote monofolliculogenesis, have been found to be successful in reducing the rate of OHSS almost to nil and the rate of multiple pregnancies to a minimum. This post-marketing study will investigate tailoring of recombinant follicle stimulating hormone (r-FSH) in a large population (N=310) of subjects from a region (North Africa/Middle East) that has not been included in previous studies of ovulation induction in subjects with chronic anovulation. The study aims to increase current knowledge of the efficacy and safety of Gonal-f, and provide fertility physicians with experience in Gonal-f treatment in anovulatory infertility, thereby contributing to the development of FSH dosing guidelines for ovulation induction by defining the optimal CLD and Low dose (LD) regimens.

Read the detailed description

Gonal-f is a recombinant form of human FSH (r-hFSH), an endogenous gonadotropin which is being produced in genetically engineered chinese hamster ovary cells and is indicated for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. It is also indicated for the development of multiple follicles in ovulatory women participating in an assisted reproductive technology (ART) programme, such as in in vitro fertilization (IVF). The primary cause of infertility in women is an abnormality of ovulation. Most of these anovulatory subjects fall into the World Health Organization (WHO) Group II category, characterized by asynchronous gonadotropin and oestrogen production and normal levels of prolactin (PRL). These subjects present with a variety of menstrual disorders, most commonly polycystic ovarian syndrome (PCOS).

Gonal-f is administered as a course of daily injections, subcutaneously into the anterior abdominal wall. A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 IU, or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate but not excessive response. A single injection of 5,000 IU urinary hCG (u-hCG) (or 250 microgram [mcg] r-hCG) should be administered after the last dose of Gonal-f and when the leading follicle has reached 17 mm in diameter. The subject is later recommended to have coitus on the day of, and the day following, hCG administration. The efficacy of Gonal-f in the treatment of WHO Group II anovulatory infertile women has been confirmed by 2 randomized, open-label, multicentric, phase III non-inferiority studies that compared Gonal-f with Metrodin® (urinary FSH) for ovulation induction. The possible serious adverse events (SAEs) associated with Gonal-f include OHSS and its possible complications, multiple pregnancies, pregnancy wastage, ectopic pregnancies and the possible risk of ovarian cancer and reproductive system neoplasms (e.g. endometrial, breast carcinoma).

OBJECTIVES

Primary objective:

  • To investigate tailoring of recombinant FSH treatment in subjects with chronic anovulation

Secondary objectives:

  • To evaluate commonly used ovulation induction regimens and treatments
  • To establish local experience with the Gonal-f pen and investigate ease of use

The study will enroll 310 eligible subjects, randomized in a 1:1 ratio to either Group I or II at the baseline visit prior to the first dose of FSH (pre-stimulation). Each subject will be refrained from the use of gonadotropins or any other ovulation stimulation therapy during the period from screening to the start of stimulation treatment. During the stimulation period, Gonal-f will be administered as a course of once daily (OD) injections, s.c. into the anterior abdominal wall through Gonal-f pen, according to either one of the following 2 step-up, low-dose regimens:

Group I: CLD regimen which recommends a starting dose of 75 IU and a first adjustment on Day 14 of stimulation, if no ovarian response is observed.

Group II: LD regimen which recommends a starting dose of 75 IU and a first adjustment on Day 7 of stimulation, if no ovarian response is observed.

For both groups, when at least 1 follicle reaches 10 to 12 mm in diameter, the Gonal-f administration will be maintained at that dose until the leading follicle reaches 17 mm or more in diameter and no more than 2 follicles have reached 14 mm in diameter. A single injection of hCG (5,000 IU u-hCG or 250 mcg r-hCG) will be administered intramuscularly or subcutaneously after the last Gonal-f injection, to trigger ovulation. Subjects will also be advised to have coitus on the day of, and the day following hCG administration. The total length of the stimulation treatment will not exceed 35 days unless an ultrasound assessment suggests imminent follicular growth and maturation and each subject will undergo one cycle of stimulation treatment only. Subjects will also be followed for a post stimulation period of up to 20 days after the triggering of ovulation by hCG injection, or cancellation of the cycle.

02

Conditions studied

  • Ovulation Induction

Keywords

  • Infertility
  • Ovulation induction
  • Gonal-f
  • Follitropin alpha
  • Polycystic ovarian syndrome
  • Anovulatory infertility
03

In context

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Premenopausal female subjects, aged between 18 and 37 years inclusive
  • Subjects willing to conceive
  • Subjects who are infertile due to chronic anovulation demonstrated by a cycle duration of > 35 days, or regular cycles with progesterone (P4) levels \< 1 nanomole/milliliter (nmol/mL) during luteal phase (Day 25)
  • Subjects who have experienced spontaneous menses, menses induced by clomiphene citrate therapy, or a positive progestin-induced withdrawal within the previous year
  • Subjects with FSH and PRL serum values within the normal range in the early follicular phase
  • Subjects with total antral follicle count (AFC) > 10 (of follicle size ≥ 2 mm and \< 11 mm) in both ovaries
  • Subjects with at least 1 patent tube, as documented by recent (within 2 years before treatment assignment) hysterosalpingography (HSG)
  • Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG or ultrasound scan
  • Subjects with body mass index (BMI) >20 and ≤32 kilogram square per meter (kg/m\^2)
  • Subjects with negative cervical Papanicolaou (PAP) test within the 6 months prior to screening
  • Male partners of female subjects with sperm compatible with non assisted fertilization
  • Subjects who are willing and able to participate in the study and have provided written, informed consent

Exclusion criteria

Exclusion Criteria:

  • Subjects with history of hypersensitivity to the active substance follitropin alpha, FSH, or to any of the excipients of Gonal-f
  • Subjects with ovarian enlargement or ovarian cyst unrelated to PCOS, and of unknown origin on ultrasound
  • Subjects with evidence of diminished ovarian reserve (cycle length \< 26 days; FSH above the upper limit of local serum FSH values, total AFC in both ovaries \< 10)
  • Subjects with myomatous uterus, which in the opinion of the investigator could impair pregnancy evolution
  • Subjects who have undergone 3 or more previous miscarriages
  • Subjects with any previous extrauterine pregnancy
  • Pregnant or lactating female subjects
  • Subjects with abnormal gynecological bleeding of unknown etiology
  • Subjects with previous history of severe OHSS
  • Subjects who have undergone operative pelvic surgery which could induce mechanical infertility (e.g tubes blockage) or pelvic inflammatory disease (PID) before treatment assignment excluding curettage and hysteroscopy
  • Subjects with tumors of the hypothalamus and pituitary gland
  • Subjects with ovarian, uterine or mammary carcinoma
  • Subjects treated with clomiphene citrate or gonadotropins within 1 month of the screening evaluation
  • Subjects with any medical condition which, in the opinion of the investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy
  • Subjects with any medical condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug
  • Subjects with any clinically significant systemic disease (e.g. insulin-dependent diabetes) or any contraindication to being pregnant and/or carrying a pregnancy to term; also including subjects with non insulin dependent diabetes mellitus (NIDDM)
  • An active substance abuser
  • Subjects with known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
  • Subjects who have simultaneously participated in another clinical trial
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
310 participants (actual)

Study arms

  • Experimental
    Group I: Chronic Low dose Protocol

    Gonal-f will be injected on the second or third day of a spontaneous or progestogen-induced menstrual cycle (Day 0), with a daily dose of 75 International Units (IU) for 7 days. Ovarian response will be assessed on Day 7 of stimulation by ultrasound scan. If no follicle has reached at least 10 to 12 millimeter (mm) diameter, stimulation will be continued with the same dose for further 7 days. On Day 14 of stimulation, if no ovarian response is seen, the dose will be increased by 37.5 IU (total 112.5 IU) and administered for the next 7 days. Subsequent increments of 37.5 IU, at intervals of 7 days up to Day 35 of stimulation would be made, depending on ovarian response.

    Drug: Recombinant FSH (follitropin alpha)

  • Experimental
    Group II: Low dose Protocol

    Gonal-f will be administered on the second or third day of a spontaneous or progestogen-induced menstrual cycle (Day 0), with a daily dose of 75 IU for 7 days. Ovarian response will be assessed on Day 7 of stimulation by ultrasound scan. If no follicle has reached at least 10 to 12 mm diameter, the dose will be increased by 37.5 IU (total 112.5 IU) and administered for the next 7 days. Subsequent increments of 37.5 IU, at intervals of 7 days up to Day 35 of stimulation will be made, depending on ovarian response.

    Drug: Recombinant FSH (follitropin alpha)

Interventions

  • DrugRecombinant FSH (follitropin alpha)

    A starting dose of 75 IU and a first adjustment on Day 14 or Day 7 of stimulation in Group I and II respectively, if no ovarian response is observed.

    Also known as: Gonal-f®, Follitropin alpha

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With a Mono-follicular Development

    Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (\>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.

    Time frame: Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})

Secondary outcomes

  1. Number of Participants With Multi-follicular Development

    Multi-follicular development was defined as the development of more than 3 follicles \>= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.

    Time frame: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})

  2. Number of Participants With Adverse Events (AEs)

    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.

    Time frame: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})

  3. Number of Participants With Multiple Pregnancies

    Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.

    Time frame: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})

  4. Number of Participants With Injection Tolerability

    Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.

    Time frame: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})

  5. Number of Participants Who Received Human Chorionic Gonadotropin (hCG)

    Time frame: End of stimulation cycle (less than or equal to [<=] 35 days)

  6. Number of Participants With Cancelled Cycles

    Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.

    Time frame: End of stimulation cycle (less than or equal to [<=] 35 days)

  7. Number of Participants With Clinical Pregnancies

    Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.

    Time frame: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})

  8. Duration of Follicle Stimulating Hormone (FSH)

    Time frame: End of stimulation cycle (less than or equal to [<=] 35 days)

  9. Total Follicle Stimulating Hormone (FSH) Dose

    Time frame: End of stimulation cycle (less than or equal to [<=] 35 days

  10. Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire

    Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.

    Time frame: On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})

07

Results

Posted Nov 7, 2012

Participant flow

Participant flow — Overall Study
MilestoneChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Started155155
Assessed for efficacy122125
Completed9594
Not completed6061
Withdrew: Dosing error11
Withdrew: Missing estradiol2528
Withdrew: Low antral follicle count10
Withdrew: Overstimulation01
Withdrew: Lost to follow-up01
Withdrew: Other3330

Outcome measures

PrimaryPercentage of Participants With a Mono-follicular Development

Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (\>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.

Time frame:
Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · percentage of participants
Percentage of Participants With a Mono-follicular Development
percentage of participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Percentage of Participants With a Mono-follicular Development56.5555.20
Statistical analysis
  • Chronic Low Dose (CLD) Protocol vs Low Dose (LD) Protocol · Chi-squared, Corrected · p = 0.9560 · Mean difference (final values): 0.0135 · 95% CI -0.1325 to 0.1637
SecondaryNumber of Participants With Multi-follicular Development

Multi-follicular development was defined as the development of more than 3 follicles \>= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.

Time frame:
Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants With Multi-follicular Development
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Multi-follicular Development1715
Statistical analysis
  • Chronic Low Dose (CLD) Protocol vs Low Dose (LD) Protocol · Chi-squared · p = 0.7924 · Risk ratio (rr): 1.088 · 95% CI 0.7642 to 1.5490
SecondaryNumber of Participants With Adverse Events (AEs)

AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.

Time frame:
Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs)
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Adverse Events (AEs)3031
SecondaryNumber of Participants With Multiple Pregnancies

Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.

Time frame:
Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants With Multiple Pregnancies
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Multiple Pregnancies31
SecondaryNumber of Participants With Injection Tolerability

Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.

Time frame:
Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants With Injection Tolerability
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Injection Tolerability5454
SecondaryNumber of Participants Who Received Human Chorionic Gonadotropin (hCG)
Time frame:
End of stimulation cycle (less than or equal to [<=] 35 days)
Reported as:
Number · participants
Number of Participants Who Received Human Chorionic Gonadotropin (hCG)
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants Who Received Human Chorionic Gonadotropin (hCG)9491
Statistical analysis
  • Chronic Low Dose (CLD) Protocol vs Low Dose (LD) Protocol · Chi-squared · p = 0.5331
SecondaryNumber of Participants With Cancelled Cycles

Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.

Time frame:
End of stimulation cycle (less than or equal to [<=] 35 days)
Reported as:
Number · participants
Number of Participants With Cancelled Cycles
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Cancelled Cycles1919
Statistical analysis
  • Chronic Low Dose (CLD) Protocol vs Low Dose (LD) Protocol · Chi-squared · p = 0.9351 · Risk ratio (rr): 1.015 · 95% CI 0.7175 to 1.4350
SecondaryNumber of Participants With Clinical Pregnancies

Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.

Time frame:
Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants With Clinical Pregnancies
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants With Clinical Pregnancies1918
SecondaryDuration of Follicle Stimulating Hormone (FSH)
Time frame:
End of stimulation cycle (less than or equal to [<=] 35 days)
Reported as:
Mean · Days
Duration of Follicle Stimulating Hormone (FSH)
DaysChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Duration of Follicle Stimulating Hormone (FSH)13.68 ± 6.3312.85 ± 5.58
SecondaryTotal Follicle Stimulating Hormone (FSH) Dose
Time frame:
End of stimulation cycle (less than or equal to [<=] 35 days
Reported as:
Mean · IU
Total Follicle Stimulating Hormone (FSH) Dose
IUChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Total Follicle Stimulating Hormone (FSH) Dose1119.41 ± 690.041155.47 ± 730.45
SecondaryNumber of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire

Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.

Time frame:
On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})
Reported as:
Number · participants
Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire
participantsChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire5875

Adverse events

Collected over AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Low Dose (CLD) Protocol—0/155 (0%)30/155 (19.4%)
Low Dose (LD) Protocol—1/155 (0.6%)30/155 (19.4%)
Most frequent serious events
Most frequent serious events
EventChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
Ectopic pregnancyReproductive system and breast disorders0/1551/155
Most frequent other events
Showing 10 of 45
Most frequent other events
EventChronic Low Dose (CLD) ProtocolLow Dose (LD) Protocol
HeadacheNervous system disorders10/15514/155
Abdominal painGastrointestinal disorders12/1557/155
DizzinessCardiac disorders1/1555/155
NauseaGastrointestinal disorders5/1555/155
Pain in stomachGastrointestinal disorders0/1554/155
Chest painGeneral disorders0/1553/155
Back painMusculoskeletal and connective tissue disorders3/1553/155
Abdominal colic painGastrointestinal disorders0/1552/155
Lower abdominal painGastrointestinal disorders2/1551/155
FeverGeneral disorders2/1550/155

Baseline characteristics

Age, Continuous
Age, Continuous(years)Chronic Low Dose (CLD) ProtocolLow Dose (LD) ProtocolTotal
Mean27.51 ± 4.4227.88 ± 4.3327.70 ± 4.37
Sex: Female, Male
Sex: Female, Male(Participants)Chronic Low Dose (CLD) ProtocolLow Dose (LD) ProtocolTotal
Female122125247
Male000
08

Study locations

3 sites
  • New Mowasat Hospital
    Salmiya, P.O.Box 6661 22077, Kuwait
  • Mount Lebanon Hospital
    Hazmieh, P.O.Box 470, Lebanon
  • King Abdel Aziz University Hospital
    Jeddah, P.O.Box 80215 21589, Saudi Arabia
09

References and documents

Publications

  • Serour GI, Aboulghar M, Al Bahar A, Hugues JN, Esmat K. Phase IV, open-label, randomized study of low-dose recombinant human follicle-stimulating hormone protocols for ovulation induction. Reprod Biol Endocrinol. 2014 Jun 18;12:52. doi: 10.1186/1477-7827-12-52. PubMed 24942155 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01081626
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Middle East FZ-LLC, United Arab Emirates, an affiliate of Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Mar 5, 2010
Start date
Mar 2009
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Nov 7, 2012
Last update
Feb 13, 2014

Study contacts

Khaled Esmat, MD
study director · Merck Serono Middle East FZ-LLC, United Arab Emirates, an affiliate of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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