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Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.


Phase 3
20 Years
45 Years
Not Enrolling
Female
Fibroids

Thank you

Trial Information

Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.


Variables noted preoperatively:

- Age

- Parity

- Ethnicity

- Ultrasound findings

Variables noted intra-operatively:

- Size of largest fibroid

- Estimated blood loss


Inclusion Criteria:



- Women between the age of 20 and 45

- Symptomatic fibroids

- Presence of regular menstrual cycles

- Ultrasound confirmation of fibroids

- Normal cervical smear

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Outcome Measure:

Intraoperative blood loss

Outcome Description:

Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Dr Bharat Bassaw, MBBS FRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mt. Hope Maternity Hospital

Authority:

Trinidad and Tobago : Ministry of Health

Study ID:

MtHopeMaternity0075

NCT ID:

NCT01581944

Start Date:

January 2008

Completion Date:

December 2011

Related Keywords:

  • Fibroids
  • myomectomy
  • GnRH
  • blood loss
  • Leiomyoma

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