NCT01472315

Brief Summary

The purposes of this study are to evaluate the degree and duration of medroxyprogesterone acetate effect as well as tolerability in postmenopausal women with nasal continuous positive airway pressure (CPAP) treated sleep apnea and to compare the effects with nasal CPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2000

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2000

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

October 3, 2011

Last Update Submit

March 8, 2013

Conditions

Sleep Apnea

Keywords

sleep apneawomenpostmenopausehormone treatment

Outcome Measures

Primary Outcomes (1)

  • polysomnography measures of sleep apnea and sleep

    Sleep stages, apnea-hypopnea index, overnight oxygen saturation values and capnograph values.

    first visit, after 14 days of MPA/placebo use and after 3 weeks washout period

Secondary Outcomes (1)

  • subjective questionnaires

    first visit, after 14 days of MPA/placebo use and after 3 weeks washout period

Study Arms (2)

medroxyprogesterone acetate

ACTIVE COMPARATOR
Drug: medroxyprogesterone acetate

Placebo

PLACEBO COMPARATOR

Placebo pills taken in the same way as the active comparator

Drug: Placebo

Interventions

medroxyprogesterone acetateDRUG

MPA hormone therapy 30mg two hours before bedtime and 30mg right before going to bed every night for two weeks period

medroxyprogesterone acetate
PlaceboDRUG

Placebo pills were taken in same way as active comparator

Placebo

Eligibility Criteria

Age42 Years - 77 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal female
  • regular controls of CPAP treatment in pulmonary clinic and regular use of CPAP device

You may not qualify if:

  • severe or unstable chronic illnesses
  • heavy current smoking (over 10 cigarettes per day)
  • medication which effects on the central nervous system
  • contraindications to progesterone therapy and current participation in any other clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Research Unit, Department of Physiology, Turku University

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

November 16, 2011

Study Start

January 1, 2000

Primary Completion

November 1, 2000

Study Completion

November 1, 2000

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

FI(1)