NCT02984696

Brief Summary

The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1.6 years

First QC Date

March 5, 2016

Last Update Submit

December 3, 2016

Conditions

Hypothalamic Amenorrhea

Outcome Measures

Primary Outcomes (1)

  • Total Anti-oxidant Capacity

    6 Month

Secondary Outcomes (5)

  • Bone Mineral Density

    6 Months

  • Osteocalcin

    6 Months

  • Estrogen levels

    6 Months

  • number of Cycles in 6 months

    6 Months

  • beta crosslaps

    6 months

Study Arms (1)

Hormonal Replace Therapy

EXPERIMENTAL

1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months

Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA

Interventions

1 mg of transdermal estradiol daily and 10mg of oral MPADRUG
Hormonal Replace Therapy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hypotalamic Amenorrhea

You may not qualify if:

  • diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
  • hypertension
  • significant liver or renal impairment
  • other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
  • neoplasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic university of Sacred Heart

Rome, Rome, 00168, Italy

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2016

First Posted

December 7, 2016

Study Start

March 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

IT(1)