Progesterone for Perimenopausal Night Sweats

NCT ID: NCT01464697

Last Updated: 2019-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2018-06-01

Brief Summary

The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.

Detailed Description

This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.

Conditions

Hot Flushes; Night Sweats

Keywords

hot flushes/hot flashes; night sweats; sleep problems; negative mood; anxiety; perimenopause; progesterone; vasomotor symptoms; depression; women's perceived change; perimenopause interference questionnaire

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oral micronized progesterone

Oral micronized progesterone is Prometrium 300 mg at bedtime daily

Group Type: EXPERIMENTAL

Oral micronized progesterone

Intervention Type: DRUG

300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks

Placebo Comparator

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks

Interventions

Oral micronized progesterone

300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks

Intervention Type: DRUG

placebo

placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Prometrium; Utrogestan

Eligibility Criteria

Inclusion Criteria

1. Between 35-58 years of age

2. At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.

3. Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.

4. At least one menstrual period within 12 months of study enrollment

5. Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.

6. Ability to understand, speak, read and write English.

7. Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.

5. Planned pregnancy or fertility treatment during the study period.

6. Women who are breastfeeding.

7. Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.

Exclusion Criteria

1. VMS without perimenopausal etiology.

2. Women who have had a hysterectomy and/or ovariectomy.

3. Peanut allergy (because peanut oil is used in the progesterone formulation.)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jerilynn Prior

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerilynn C Prior, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Women's Health Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

References

Prior JC, Hitchcock, CL. Progesterone for Vasomotor Symptoms: A 12-week Randomized, Masked Placebo-controlled Trial in Healthy, Normal-Weight Women 1-10 Years Since Final Menstrual Flow (Abstract). Endocrine Reviews 31(3): S51, 2010.

Reference Type: BACKGROUND

Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms--a placebo-controlled randomized trial in healthy postmenopausal women. Menopause. 2012 Aug;19(8):886-93. doi: 10.1097/gme.0b013e318247f07a.

Reference Type: BACKGROUND

PMID: 22453200 (View on PubMed)

Prior JC, Cameron A, Hitchcock CL, et al. Oral Micronized Progesterone Beneficial for Perimenopausal Hot Flushes/Flashes and Night Sweats. Endocrine Reviews 2018;39(2) Abstract-oral presentation at Endocrine Society Conference, Chicago, 2018.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.cemcor.ca

Centre for Menstrual Cycle and Ovulation Research

Other Identifiers

H10-02975

Identifier Type: -

Identifier Source: org_study_id