PRIMROSE 2: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

• Sponsor: ObsEva SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03070951
• Collaborator: (none)
• Enrollment: 511
• Locations: 96
• Arms: 5
• Actual Duration (Months): 40.4
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Heavy Menstrual Bleeding	Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back; Drug: Add-back	Phase 3

Detailed Description

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Study Design

• Study Type: Interventional
• Actual Enrollment: 511 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
• Actual Study Start Date: May 23, 2017
• Actual Primary Completion Date: Sep 16, 2019
• Actual Study Completion Date: Oct 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OBE2109 dose 1 (100mg) + Placebo Add-back	Drug: OBE2109; OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match OBE2109; Placebo to match OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match Add-back; Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Experimental: OBE2109 dose 1 (100mg) + Add-back	Drug: OBE2109; OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match OBE2109; Placebo to match OBE2109 100mg tablets for oral administration once daily; Drug: Add-back; Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Experimental: OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back	Drug: OBE2109; OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match Add-back; Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily; Drug: Add-back; Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Experimental: OBE2109 dose 2 (200mg) + Add-back	Drug: OBE2109; OBE2109 100mg tablets for oral administration once daily; Drug: Add-back; Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Placebo Comparator: Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back	Drug: OBE2109; OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match OBE2109; Placebo to match OBE2109 100mg tablets for oral administration once daily; Drug: Placebo to match Add-back; Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily; Drug: Add-back; Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Outcome Measures

Primary Outcome Measures

1. Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 [From baseline to Week 24]

   Assessed using the alkaline hematin method

Secondary Outcome Measures

1. Time to reduced menstrual blood loss [Up to Week 52]

   Assessed using the alkaline hematin method

2. Amenorrhea [Up to Week 52]

   Assessed using the alkaline hematin method

3. Time to amenorrhea [Up to Week 52]

4. Number of days of uterine bleeding for the last 28-day interval prior to Week 24 [last 28-day interval prior to Week 24]

   Assessed using the alkaline hematin method

5. Number of days of uterine bleeding for each 28-day interval [Up to Week 52]

   Assessed using the alkaline hematin method

Other Outcome Measures

1. Bone Mineral Density (BMD) [From baseline up to Week 76]

   Assessed by dual-energy X-ray absorptiometry (DXA) scan

2. Endometrial biopsy [From baseline up to Week 52]

   Assessed by histology

3. Adverse events [Up to Week 76]

   Frequency and severity of Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Premenopausal woman at screening.

• Body Mass Index ≥ 18 kg/m2.

• Menstrual cycles ≥ 21 days and ≤ 40 days.

• Presence of uterine fibroids.

• Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

Key Exclusion Criteria:

• The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.

• History of uterus surgery that would interfere with the study.

• The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.

• Undiagnosed abnormal uterine bleeding.

• Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site reference ID 905	Chino	California	United States	91710
2	Site reference ID 918	Huntington Park	California	United States	29572
3	Site reference ID 902	San Diego	California	United States	92123
4	Site reference ID 903	Denver	Colorado	United States	80209
5	Site reference ID 913	Bradenton	Florida	United States	34209
6	Site reference ID 912	Orlando	Florida	United States	32806
7	Site reference ID 915	Augusta	Georgia	United States	30912
8	Site reference ID 924	Nampa	Idaho	United States	83687
9	Site reference ID 926	Covington	Louisiana	United States	70433
10	Site reference ID 927	Metairie	Louisiana	United States	70006
11	Site reference ID 900	Metairie	Louisiana	United States	92123
12	Site reference ID 901	Canton	Michigan	United States	48187
13	Site reference ID 932	Detroit	Michigan	United States	48201
14	Site reference ID 916	Jefferson City	Missouri	United States	65109
15	Site reference ID 930	Albuquerque	New Mexico	United States	87102
16	Site reference ID 933	West Seneca	New York	United States	14224
17	Site reference ID 931	Hamlet	North Carolina	United States	28345
18	Site reference ID 914	Westerville	Ohio	United States	43081
19	Site reference ID 928	Erie	Pennsylvania	United States	16507
20	Site reference ID 919	West Columbia	South Carolina	United States	37203
21	Site reference ID 907	Houston	Texas	United States	77058
22	Site reference ID 911	Salt Lake City	Utah	United States	84124
23	Site reference ID 917	Madison	Wisconsin	United States	53717
24	Site reference ID 265	Gabrovo		Bulgaria
25	Site reference ID 255	Pleven		Bulgaria
26	Site reference ID 258	Plovdiv		Bulgaria
27	Site reference ID 266	Sliven		Bulgaria
28	Site reference ID 264	Smolyan		Bulgaria
29	Site reference ID 251	Sofia		Bulgaria
30	Site reference ID 252	Sofia		Bulgaria
31	Site reference ID 254	Sofia		Bulgaria
32	Site reference ID 256	Sofia		Bulgaria
33	Site reference ID 257	Sofia		Bulgaria
34	Site reference ID 267	Sofia		Bulgaria
35	Site reference ID 281	Praha		Czechia
36	Site reference ID 286	Praha		Czechia
37	Site reference ID 287	Praha		Czechia
38	Site reference ID 288	Praha		Czechia
39	Site reference ID 283	Písek		Czechia
40	Site reference ID 284	Příbram		Czechia
41	Site reference ID 289	Tábor		Czechia
42	Site reference ID 282	Vsetín		Czechia
43	Site reference ID 285	České Budějovice		Czechia
44	Site reference ID 315	Baja		Hungary
45	Site reference ID 303	Budapest		Hungary
46	Site reference ID 307	Budapest		Hungary
47	Site reference ID 301	Debrecen		Hungary
48	Site reference ID 308	Debrecen		Hungary
49	Site reference ID 313	Debrecen		Hungary
50	Site reference ID 314	Kecskemét		Hungary
51	Site reference ID 304	Kistarcsa		Hungary
52	Site reference ID 306	Nyíregyháza		Hungary
53	Site reference ID 451	Riga		Latvia
54	Site reference ID 452	Riga		Latvia
55	Site reference ID 454	Riga		Latvia
56	Site reference ID 463	Kaunas		Lithuania
57	Site reference ID 460	Vilnius		Lithuania
58	Site reference ID 461	Vilnius		Lithuania
59	Site reference ID 464	Vilnius		Lithuania
60	Site reference ID 502	Białystok		Poland
61	Site reference ID 504	Katowice		Poland
62	Site reference ID 509	Katowice		Poland
63	Site reference ID 513	Katowice		Poland
64	Site reference ID 514	Katowice		Poland
65	Site reference ID 501	Knurów		Poland
66	Site reference ID 506	Lublin		Poland
67	Site reference ID 508	Lublin		Poland
68	Site reference ID 511	Lublin		Poland
69	Site reference ID 519	Piaseczno		Poland
70	Site reference ID 518	Poznań		Poland
71	Site reference ID 505	Przemyśl		Poland
72	Site reference ID 503	Szczecin		Poland
73	Site reference ID 507	Warsaw		Poland
74	Site reference ID 510	Łódź		Poland
75	Site reference ID 517	Łódź		Poland
76	Site reference ID 512	Świdnik		Poland
77	Site reference ID 606	Braşov		Romania
78	Site reference ID 601	Bucuresti		Romania
79	Site reference ID 603	Bucuresti		Romania
80	Site reference ID 604	Bucuresti		Romania
81	Site reference ID 605	Târgu-Mureş		Romania
82	Site reference ID 813	Chernivtsi		Ukraine
83	Site reference ID 801	Ivano-Frankivs'k		Ukraine
84	Site reference ID 814	Kharkiv		Ukraine
85	Site reference ID 802	Kyiv		Ukraine
86	Site reference ID 803	Kyiv		Ukraine
87	Site reference ID 805	Kyiv		Ukraine
88	Site reference ID 806	Kyiv		Ukraine
89	Site reference ID 807	Kyiv		Ukraine
90	Site reference ID 804	L'viv		Ukraine
91	Site reference ID 811	Odesa		Ukraine
92	Site reference ID 808	Ternopil'		Ukraine
93	Site reference ID 817	Vinnytsia		Ukraine
94	Site reference ID 812	Zaporizhzhya		Ukraine
95	Site reference ID 815	Zaporizhzhya		Ukraine
96	Site reference ID 816	Zaporizhzhya		Ukraine

Sponsors and Collaborators

• ObsEva SA

Investigators

• Study Director: ObsEva SA, Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ObsEva SA
• ClinicalTrials.gov Identifier: NCT03070951
• Other Study ID Numbers: 16-OBE2109-009
• First Posted: Mar 6, 2017
• Last Update Posted: Mar 5, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ObsEva SA: Uterine Fibroid; Leiomyomata; Heavy Menstrual Bleeding; HMB; Heavy Uterine Bleeding; Menorrhagia; OBE2109 + Add-back
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage; OBE2109

Study Results

No Results Posted as of Mar 5, 2021