J Clin Gynecol Obstet

Journal of Clinical Gynecology and Obstetrics, ISSN 1927-1271 print, 1927-128X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Gynecol Obstet and Elmer Press Inc

Journal website http://www.jcgo.org

Original Article

Volume 2, Number 1, June 2013, pages 31-37

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

**Table 1.** Characteristics of the Studies, Duration of Mifepristone Treatment, Doses Administered and Number of Subjects Included in Each Clinical Study of Endometriosis
Study	Characteristics of the study and duration of the treatment	Dosage mifepristone administered	Total
1	6 months treatment + 6 months follow-up (randomized)			13	---	13	26
2	6 months treatment (no follow-up) (randomized)	90	90	90	90	---	360
Total	---	90	90	103	90	13	386

Table 1. Characteristics of the Studies, Duration of Mifepristone Treatment, Doses Administered and Number of Subjects Included in Each Clinical Study of Endometriosis

Study

Characteristics of the study and duration of the treatment

Dosage mifepristone administered

Total

Placebo

2.5 mg

5 mg

10 mg

25 mg

6 months treatment + 6 months follow-up (randomized)

---

6 months treatment (no follow-up) (randomized)

---

360

Total

---

103

386

**Table 2.** Characteristics of the Studies, Duration of Mifepristone Treatment, Doses Administered and Number of Subjects Included in Each Clinical Study of Fibroids
Study	Characteristics of the study, duration of treatment	Dosage mifepristone administered	Total
1	3 months treatment (randomized)	---	---	50	50	100
2	3 months treatment + 6 months follow-up (randomized)	---	---	48	52	100
3	6 months treatment + 12 months follow-up (randomized)	---	---	88	88	176
4	9 months treatment + 18 months follow-up (randomized)	---	---	35	35	70
5	3 months treatment + 9 months follow-up	---	110	110	---	220
6	3 months treatment (no follow-up) (randomized)	60	---	60	---	120
7	3 months treatment (pre-surgery) (randomized)	---	71	75	---	146
Total	---	60	181	466	225	932

Table 2. Characteristics of the Studies, Duration of Mifepristone Treatment, Doses Administered and Number of Subjects Included in Each Clinical Study of Fibroids

Study

Characteristics of the study, duration of treatment

Dosage mifepristone administered

Total

Placebo

2.5 mg

5 mg

10 mg

3 months treatment (randomized)

---

100

3 months treatment + 6 months follow-up (randomized)

---

100

6 months treatment + 12 months follow-up (randomized)

---

176

9 months treatment + 18 months follow-up (randomized)

---

3 months treatment + 9 months follow-up

---

110

---

220

3 months treatment (no follow-up) (randomized)

---

120

3 months treatment (pre-surgery) (randomized)

---

146

Total

---

181

466

225

932

**Table 3.** Variables in Those Women Who Underwent Two or More Mifepristone Treatments
Results	Endometriosis N = 386	Fibroids N = 932	P
Subjects repeating treatments	101/386 (26.2%)	36/932 (3.9%)	< 0.001
With 2 treatments cycles	62/101 (61.4%)	34/36 (94.4%)	< 0.001
With 3 treatments cycles	32/101 (31.7%)	2/36 (5.6%)	< 0.001
With 4 treatments cycles	7/101 (6.9%)	0/36 (0.0%)	0.053
Mean treatment period (months)	18 ± 2.0; 95% CI = 17.4 - 22; Min = 12; Max = 24	7.3 ± 2.5; 95% CI = 6.5 - 8.2; Min = 6; Max = 15
Mean “rest” interval (months)	8.3 ± 5.3; 95% CI = 7.6 – 9; Min =3; Max = 30	9.7 ± 6.2; 95% CI = 7.6 - 11.9; Min = 3; Max = 30
Median of mifepristone dose	5 mg	5 mg	-----
Liver transaminases raised	4/101 (4.0%)	2/36 (5.6%)	0.344
Hot flushes (%)	18/101 (17.8%)	8/36 (22.2%)	0.282
Endometrial thickness > 8 mm	26/101 (25.7%)	8/36 (22.2%)	0.337
Pregnancies	8/101 (7.9%)	0/36 (0.0%)	0.041
Live born baby	8	----	----
Women who refused final endometrial biopsies	18/101 (17.8%)	8/36 (22.2%)	0.282
Final biopsies performed over the total number of possible final endometrial biopsies	197/248 (79.4%)	29/74 (39.2%)	< 0.001
PAEC	19/197 (9.6%)	9/35 (25.7%)	0.004

Table 3. Variables in Those Women Who Underwent Two or More Mifepristone Treatments

Results

Endometriosis
N = 386

Fibroids
N = 932

Subjects repeating treatments

101/386 (26.2%)

36/932 (3.9%)

< 0.001

With 2 treatments cycles

62/101 (61.4%)

34/36 (94.4%)

< 0.001

With 3 treatments cycles

32/101 (31.7%)

2/36 (5.6%)

< 0.001

With 4 treatments cycles

7/101 (6.9%)

0/36 (0.0%)

0.053

Mean treatment period (months)

18 ± 2.0; 95% CI = 17.4 - 22; Min = 12; Max = 24

7.3 ± 2.5; 95% CI = 6.5 - 8.2; Min = 6; Max = 15

Mean “rest” interval (months)

8.3 ± 5.3; 95% CI = 7.6 – 9; Min =3; Max = 30

9.7 ± 6.2; 95% CI = 7.6 - 11.9; Min = 3; Max = 30

Median of mifepristone dose

5 mg

-----

Liver transaminases raised

4/101 (4.0%)

2/36 (5.6%)

0.344

Hot flushes (%)

18/101 (17.8%)

8/36 (22.2%)

0.282

Endometrial thickness > 8 mm

26/101 (25.7%)

8/36 (22.2%)

0.337

Pregnancies

8/101 (7.9%)

0/36 (0.0%)

0.041

Live born baby

----

Women who refused final endometrial biopsies

18/101 (17.8%)

8/36 (22.2%)

0.282

Final biopsies performed over the total number of possible final endometrial biopsies

197/248 (79.4%)

29/74 (39.2%)

< 0.001

PAEC

19/197 (9.6%)

9/35 (25.7%)

0.004