Psychological Impact of Amenorrhea in Women With Endometriosis

University of Cagliari

Status and phase: Unknown; Phase 4

Conditions: Quality of Life; Amenorrhea; Endometriosis

Treatments: Drug: Add back therapy 1 (tibolone); Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre); Drug: Add back therapy 2 (calcium carbonate/colecalciferol); Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)

Study type: Interventional

Funder types: Other

Identifiers

NCT02393482

AMENORREA

Details and patient eligibility

About

The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical, echographical or surgical diagnosis of endometriosis

Exclusion criteria

• Comorbidity
• Psychiatric diseases
• Refusal or inability to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Balanced estroprogestins

Active Comparator group

Description:

Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days.

Treatment:

Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)

GnRHa

Active Comparator group

Description:

Women assigned to this arm will assume Leuprorelin acetate (3,75 mg/2ml), one intramuscular administration every 28 days. After 45 days of treatment, therapy will be implemented with Tibolone 5 mg, one tablet daily orally, and Calcium carbonate/colecalciferol (500 mg/400 UI), one tablet daily orally. This therapy will be prosecuted for the remaining 135 days of treatment.

Treatment:

Drug: Add back therapy 2 (calcium carbonate/colecalciferol)

Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)

Drug: Add back therapy 1 (tibolone)