Phase 3
N=189
Progesterone for Perimenopausal Night Sweats
Hot Flushes · Night Sweats
Bottom Line
View on ClinicalTrials.gov: NCT01464697 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks — 5.5; 7.1 Units of Vasomotor Symptom Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral micronized progesterone (Drug); placebo (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks |
5.5; 7.1 | — |
| PRIMARY Frequency of VMS |
2.4; 3.0 | — |
| PRIMARY Severity of VMS |
1.4; 1.5 | — |
| PRIMARY VMS Score by Early Perimenopause |
4.4; 3.9 | — |
| PRIMARY VMS Score by Late Perimenopause |
5.9; 8.8 | — |
| PRIMARY Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score |
11.8; 15.1 | — |
| SECONDARY Sleep Problems |
0.8; 1.0 | — |
| SECONDARY Anxiety |
0.5; 0.6 | — |
| SECONDARY Women's Perceived Changes in Daytime Hot Flushes for Whole Population |
-2.3; -1.8 | — |
| SECONDARY Women's Perceived Changes in Night Sweats for Whole Population |
-2.5; -1.9 | — |
| SECONDARY Women's Perceived Changes in Quality of Sleep for Whole Population |
2.0; 0.0 | — |
| SECONDARY Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women |
22.6; 28.2 | — |
| SECONDARY Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause |
25.7; 33.0 | — |
| SECONDARY Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause |
21.3; 25.6 | — |
| SECONDARY Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women |
22.4; 27.8 | — |
| SECONDARY Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women |
22.7; 29.3 | — |
| SECONDARY Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause |
-1.7; -1.3 | — |
| SECONDARY Women's Perceived Changes in Night Sweats in Early Perimenopause |
-2.9; -1.9 | — |
| SECONDARY Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause |
-2.5; -2.0 | — |
| SECONDARY Women's Perceived Changes in Night Sweats in Late Perimenopause |
-2.4; -1.9 | — |
| SECONDARY Depression Related to Progesterone Therapy in Whole Population |
4.8; 5.4 | — |
| SECONDARY Depression Related to Progesterone Therapy in Early Perimenopause |
6.0; 5.4 | — |
| SECONDARY Depression Related to Progesterone Therapy in Late Perimenopause |
4.4; 5.4 | — |
| SECONDARY Percentage of Women With Perceived Changes in Menstrual Flow |
65; 74 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Between 35-58 years of age
- 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.
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- At least one menstrual period within 12 months of study enrollment
- Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
- Ability to understand, speak, read and write English.
- 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.
Exclusion Criteria
- VMS without perimenopausal etiology.
- Women who have had a hysterectomy and/or ovariectomy.
- Peanut allergy (because peanut oil is used in the progesterone formulation.)
- Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
- Planned pregnancy or fertility treatment during the study period.
- Women who are breastfeeding.
- 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.
Data sourced from ClinicalTrials.gov (NCT01464697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.