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Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

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ClinicalTrials.gov Identifier: NCT02440750
Recruitment Status : Unknown
Verified March 2016 by Stefano Angioni, University of Cagliari.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2015
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari

Brief Summary:
The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Procedure: operative hysteroscopy Drug: Dienogest Drug: Ulipristal acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

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Arm Intervention/treatment
Experimental: Dienogest
Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
Procedure: operative hysteroscopy
Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.

Drug: Dienogest
21 days administration of dienogest 2 mg/die
Other Name: Visanne

Experimental: Ulipristal acetate
Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
Procedure: operative hysteroscopy
Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.

Drug: Ulipristal acetate
21 days administration of ulipristal acetate 5 mg/die
Other Name: Esmya




Primary Outcome Measures :
  1. Endometrial thickness [ Time Frame: Change in mm from baseline after farmacological therapy ]
    We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm


Secondary Outcome Measures :
  1. Ovarian follicle dimensions [ Time Frame: Change in mm from baseline after farmacological therapy ]
    We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm

  2. Endometrial appearance [ Time Frame: Change from baseline after farmacological therapy ]
    We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment

  3. Operative time [ Time Frame: Within 2 hours after the end of the hysteroscopy ]
    It will be expressed in minutes



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion Criteria:

  • pregnancy
  • other hormonal therapy in the previous 8 weeks
  • hepatic or renal impairment
  • any medical condition that would increase the surgical risk
  • refusal or unable to sign written consent

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Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02440750     History of Changes
Other Study ID Numbers: HYSTERO
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Dienogest
Ulipristal acetate
Nandrolone
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Hormones
Anabolic Agents