FibroidsPhase 3NCT01581944
Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
A Phase 3 study testing 2 Doses Goserelin and 3 Doses Goserelin in people with Fibroids, run by Mt. Hope Maternity Hospital at 1 site in Trinidad and Tobago.
Trial summary
Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Fibroids
- What is being tested?
- 2 Doses Goserelin and 3 Doses Goserelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- Jan 2008to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the age of 20 and 45
- Symptomatic fibroids
- Presence of regular menstrual cycles
- Ultrasound confirmation of fibroids
- Normal cervical smear
Who cannot join
- Pregnancy
- The length of hospital stay was calculated in number of days from the date of the to the date of discharge
- Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital
Champs Fleurs, 00000
About this study
Official title: Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.
Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.
In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.
In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.
Read the detailed description
Variables noted preoperatively:
- Age
- Parity
- Ethnicity
- Ultrasound findings
Variables noted intra-operatively:
- Size of largest fibroid
- Estimated blood loss
- Conditions
- Fibroids
- Being tested
- 2 Doses Goserelin, 3 Doses Goserelin
- Keywords
- myomectomy, GnRH, blood loss
- Medical subject headings
- Leiomyoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Doses GoserelinDrug
Also called Gonadotropin Releasing Hormone Agonist
3.6mg administered monthly for 2 months prior to myomectomy
3 Doses GoserelinDrug
Also called Gonadotropin Releasing Hormone Agonist
3.6mg administered monthly for 3 months prior to myomectomy
| Study group | Role | What they receive |
|---|---|---|
| No Treatment (Control) | No intervention | Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy. |
| 2 Doses Goserelin | Experimental | Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy. Receives: Drug: 2 Doses Goserelin |
| 3 Doses Goserelin | Experimental | Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections). Receives: Drug: 3 Doses Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.
Measured: 3 months
Secondary outcomes (4)
Blood transfusion requirement
The hemoglobin level of each woman was measured on day 1 post operative and a blood transfusion was recommended if the hemoglobin level was <9g/dl.
Measured: Intraoperatively and in the postoperative period
The level of difficulty in enucleation of the fibroid and in achieving hemostasis.
The surgeons were asked to record the level of difficulty in enucleation (shelling out) of the fibroids and in securing hemostasis. They were asked to state if it was Easy, moderate or difficult.
Measured: Immediately after the operation
Length of operation
The length of operation was calculated from the skin incision to closure (minutes).
Measured: Immediately after operation
Length of hospital stay
The length of hospital stay was calculated in number of days from the date of the to the date of discharge.
Measured: Number of days from operation date to discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Hope Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bharat Bassaw, Mt. Hope Maternity Hospital
- Investigators
- Dr Bharat Bassaw, MBBS FRCOG, Principal investigator, Mt. Hope Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581944
- Sponsor's protocol ID
- MtHopeMaternity0075
- Status last verified
- Apr 2012
- First submitted
- 17 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.
- ClinicalTrials.gov ID
- NCT01581944
- Acronym / sponsor ID
- MtHopeMaternity0075
- Conditions
- Fibroids
- Keywords
- myomectomy, GnRH, blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mt. Hope Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.
In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.
In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.
Detailed description
Variables noted preoperatively:
- Age
- Parity
- Ethnicity
- Ultrasound findings
Variables noted intra-operatively:
- Size of largest fibroid
- Estimated blood loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Treatment (Control) | No intervention | –Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy. |
| 2 Doses Goserelin | Experimental | Drug: 2 Doses GoserelinWomen were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy. |
| 3 Doses Goserelin | Experimental | Drug: 3 Doses GoserelinWomen were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the age of 20 and 45
- Symptomatic fibroids
- Presence of regular menstrual cycles
- Ultrasound confirmation of fibroids
- Normal cervical smear
Key exclusion criteria (3 listed)
- Pregnancy
- The length of hospital stay was calculated in number of days from the date of the to the date of discharge
- Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 Doses GoserelinAlso: Gonadotropin Releasing Hormone Agonist3.6mg administered monthly for 2 months prior to myomectomy | Drug | 2 Doses Goserelin |
| 3 Doses GoserelinAlso: Gonadotropin Releasing Hormone Agonist3.6mg administered monthly for 3 months prior to myomectomy | Drug | 3 Doses Goserelin |
Primary outcome
Intraoperative blood loss
Time frame: 3 months
Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.
4 secondary outcomes
Blood transfusion requirement
Time frame: Intraoperatively and in the postoperative period
The level of difficulty in enucleation of the fibroid and in achieving hemostasis.
Time frame: Immediately after the operation
Length of operation
Time frame: Immediately after operation
Length of hospital stay
Time frame: Number of days from operation date to discharge date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Bharat Bassaw, MBBS FRCOG principal investigator
Mt. Hope Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2 Doses Goserelin and 3 Doses Goserelin in people with Fibroids, run by Mt. Hope Maternity Hospital at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.